Ultrasonic interface unit and method
The ultrasonic interface unit addresses the inefficiencies in current ultrasonic monitoring systems by enabling communication and data processing between ultrasonic sensing devices and patient monitors, allowing for cost-effective and space-efficient continuous monitoring of clinical parameters.
Patent Information
- Application Number
- JP2022517759
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- Priority Date
- 2019-10-07
- Filing Date
- 2020-09-20
- Publication Date
- 2025-06-18
- Estimated Expiration
- 2040-09-20
AI Technical Summary
Current ultrasonic sensing and patient monitoring devices lack the necessary functionality to efficiently interface and process ultrasonic data for continuous monitoring of clinical parameters, leading to increased costs and space requirements for dedicated systems.
An ultrasonic interface unit that can be communicably coupled to both ultrasonic sensing devices and patient monitoring units, processing ultrasonic data to derive physiological or anatomical parameters and communicating these to the patient monitor, while also configuring the ultrasonic sensing device to acquire suitable data for monitoring.
Enables the use of existing ultrasonic and patient monitoring devices for ultrasonic monitoring applications without the need for a dedicated system, reducing costs and space requirements while providing efficient data processing and display.
Smart Images

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Abstract
Description
Technical Field
[0001] The present application relates to an interface unit for an ultrasonic system, and more particularly, for interfacing between an ultrasonic sensing device and a patient monitoring system.
Background Art
[0002] The use of ultrasound in a monitoring function for monitoring specific clinical parameters of a subject is a growing area of interest. Ultrasonic data representing the subject can be continuously acquired and processed by one or more algorithms to derive measurements or parameters related to the subject. For example, changes in the size of an anatomical body over time (e.g., the left ventricle of the heart) can be derived and monitored from ultrasonic data and used to perform a clinical assessment (e.g., cardiac function).
[0003] When an ultrasonic system is used in a monitoring function, measurements from the generated ultrasonic images are calculated from the ultrasonic data, sent to a monitor for graphical rendered display, and made available for interpretation by a clinical expert. Ultrasound has the potential to become a widely adopted monitoring tool in the medical environment.
[0004] As one exemplary application, the use of transesophageal echocardiography (TEE) for continuous cardiac monitoring has been proposed within the medical community. In this context, TEE is used not only for qualitative observation of dynamic cardiac motion via conventional ultrasound imaging, but also for performing quantitative measurements such as left ventricular (LV) volume, stroke volume (SV), and cardiac output (CO). Model-based segmentation (MBS) can be used here to assist, for example, to automatically segment one or more ventricles, enabling anatomical quantification. Other methods for performing quantitative measurements are also possible, such as full MBS performed on end-diastolic (ED) frames, followed by 2D or 3D tracking of segmentation boundaries performed over other frames of the cardiac cycle.
[0005] Transthoracic echocardiography (TTE) is also used for cardiac function assessment in certain environments, particularly in types of environments such as the medical field and primary care, but may also be possible in other environments.
[0006] Patient monitors collect and display information from a variety of sensors in a hospital environment, including but not limited to heart rate, blood pressure, body temperature, respiratory rate, oxygen saturation, etc. The monitor is a central hub for accessing any information about a patient's vital signs. The information can be rendered over a long period of time in a monitor database or communicated to a higher-level Picture Archiving and Communication System (PACS). The monitor is also configured to sound an alarm in response to the evaluation of specific measurements.
[0007] The use of ultrasound in a monitoring context creates new requirements for the functionality of devices such as ultrasound systems and patient monitors. Measurements must be calculated from ultrasound data (e.g., ultrasound images) and preferably presented in a meaningful way for observation by in-room clinical staff without interfering with current standard of care. For example, measurements (waveforms or numerical data) generated from ultrasound data need to be transferred to and displayed on the patient monitor.
[0008] In addition, the ultrasonic sensing device must be controlled to acquire ultrasonic data based on an ongoing format suitable for deriving and continuously monitoring clinical parameters of interest.
Summary of the Invention
Problems to be Solved by the Invention
[0009] These requirements create new technical demands that go beyond what is provided by current ultrasonic sensing and patient monitoring devices, and as a result, a dedicated ultrasonic monitoring system is under development to facilitate this. These impose a significant cost burden on hospitals and other care centers, and also require additional space requirements in the clinical room to accommodate the new system.
[0010] Improvements in the field of ultrasonic monitoring that can address one or more of these problems would be advantageous.
Means for Solving the Problems
[0011] The present invention is defined in the claims.
[0012] According to an embodiment in accordance with an aspect of the present invention, there is provided an ultrasonic interface unit that can be communicably coupled to an ultrasonic sensing device and a patient monitoring unit during use, and the ultrasonic interface unit, during use, receives acquired ultrasonic data representing a subject from the ultrasonic sensing device and performs processing of the ultrasonic data to derive at least one physiological or anatomical parameter related to the subject; and generates a data output representing the derived at least one physiological or anatomical parameter and communicates the data output to the patient monitoring unit; and Configuring the ultrasonic sensing device to obtain ultrasonic data suitable for monitoring at least one physiological or anatomical parameter, and performing a configuration function including communicating with the ultrasonic sensing device to adjust one or more operating parameters of the ultrasonic sensing device is configured to perform.
[0013] In one advantageous set of embodiments, the ultrasonic interface unit is further configured to generate guidance information for guiding the user during positioning of the ultrasonic transducer unit of the ultrasonic sensing device with respect to the subject for obtaining ultrasonic data suitable for obtaining at least one physiological or anatomical parameter. The ultrasonic interface unit is configured to generate a display output for use when controlling the display unit to display the guidance information.
[0014] The interface unit effectively provides a general-purpose processor unit that enables any ultrasonic sensing device and patient monitor to be utilized for performing ultrasonic monitoring. The interface unit includes means for deriving measurements from the ultrasonic data, realizing the processing functions required for monitoring, and means for communicating these to the patient monitor for display and rendering. This also includes means for controlling the ultrasonic device to acquire data in a mode, manner, or format suitable for deriving and monitoring these measurements.
[0015] Thus, the interface unit effectively enables any ultrasonic and patient monitoring device to be utilized for ultrasonic monitoring. This avoids the need to purchase and implement a dedicated ultrasonic monitoring system, thus saving both space and clinical resources. A single set of ultrasonic scanning and patient monitoring equipment can be used for both conventional ultrasonic scanning and patient monitoring applications, and, when necessary, ultrasonic monitoring applications.
[0016] In an embodiment, the interface unit provides a retrofit function that enables an existing ultrasound device and patient monitor to be utilized for patient monitoring. The interface unit is a plug-in unit configured to connect to a separate ultrasound sensing device and a patient monitoring unit. However, in other embodiments, the interface unit is integrated, for example, within the ultrasound device or the patient monitor unit to add an ultrasound monitoring function to these devices.
[0017] The interface unit is preferably configured to repeatedly receive ultrasound data from the ultrasound sensing device and repeatedly determine values of at least one physiological or anatomical parameter. In this way, the interface unit realizes the monitoring of at least one physiological or anatomical parameter.
[0018] Monitoring in the context of this disclosure means, for example, monitoring a parameter (e.g., in a present progressive or continuous manner) over a period of time, e.g., repeatedly determining the value of the parameter, and, for example, taking a record of this value.
[0019] The interface unit comprises a processing component comprising one or more processors for performing one or more of the above steps.
[0020] As described above, the interface unit is configured to be communicably coupled to the patient monitoring unit during use. By way of example, the interface unit is configured to connect to the patient monitoring unit via a wired or wireless connection. In some embodiments, this is configured to connect via the facility's wireless LAN. In some embodiments, the interface unit includes a wired or wireless connection port to facilitate this. The interface unit is configured to communicate physiological and / or anatomical parameter measurements derived by the interface unit during use. These are, for example, displayed on the screen of the patient monitoring unit and / or stored or cached in the patient monitoring unit. These are, for example, rendered on the display of the patient monitor, i.e., display changes in parameters over time.
[0021] The interface unit is configured to perform a configuration function that includes communicating with an ultrasonic sensing device to adjust one or more operating parameters of the ultrasonic sensing device so as to configure the ultrasonic sensing device to acquire ultrasonic data suitable for monitoring physiological or anatomical parameters. As will be discussed below, there are various ways to achieve this.
[0022] In some embodiments, the ultrasonic sensing device includes local means for controlling ultrasonic data acquisition in a manner suitable for performing ultrasonic monitoring. For example, this includes one or more local operating settings or modes for operating ultrasonic data acquisition in a manner suitable for performing ultrasonic monitoring of at least one physiological or anatomical parameter. In this case, the interface unit detects this and permits the ultrasonic sensing device to operate according to this local setting or mode.
[0023] In some embodiments, the ultrasonic sensing device does not include any dedicated settings or modes for acquiring data suitable for performing ultrasonic monitoring. In these cases, the interface unit detects this and is configured to instruct the ultrasonic sensing device as to the mode or manner of data acquisition such that data suitable for monitoring at least one physiological or anatomical parameter is acquired.
[0024] In some embodiments, the patient monitoring unit receives and monitors one or more physiological or anatomical parameters derived by one or more ultrasounds and includes one or more preconfigured or user-configured settings or modes. The interface unit is configured to perform configuration functions in accordance with this setting or mode of the patient monitoring unit during use. For example, the patient monitor communicates one or more specific parameters to be derived from the ultrasonic data, and the interface unit configures ultrasonic operation parameters, such as to effect acquisition of ultrasonic data suitable for deriving these one or more parameters.
[0025] The patient monitoring unit includes user interface means for receiving input from the user indicating one or more parameters to be acquired, and the interface unit receives, during use, an indication of these one or more parameters from the patient monitoring unit and configures the ultrasonic operation parameters accordingly.
[0026] The above are merely exemplary operating procedures, and as will be described in more detail and outlined in the following description, many other specific procedures are possible.
[0027] According to one possible set of embodiments, the ultrasonic interface unit is configured to supply power to the ultrasonic sensing device to drive ultrasonic transmission by the ultrasonic transducer of the ultrasonic sensing device during use. This enables, for example, a stand-alone peripheral ultrasonic transducer unit (e.g., an ultrasonic probe or scanner) to be utilized as an ultrasonic device without the need for an additional power supply to drive the transducer unit. This means that a full diagnostic ultrasonic system is not required, and only a single peripheral ultrasonic scanner or transducer unit is needed, which is powered by the ultrasonic interface unit, allowing for a very simple and smooth setup.
[0028] Thus, in this case, the ultrasonic interface unit provides a power source for the ultrasonic transducer of the ultrasonic sensing device.
[0029] As an example, the ultrasonic sensing device is an ultrasonic transducer unit comprising one or more ultrasonic transducers.
[0030] As an example, the ultrasonic interface unit is configured to generate drive signals for driving ultrasonic transmission by one or more ultrasonic transducers of the ultrasonic transducer unit, and the configuration function includes configuring parameters of the drive signals. The drive signal is an electrical drive signal that energizes the ultrasonic transducer according to a desired transmission pattern for acquiring ultrasonic data in an appropriate format or mode so as to induce acquisition of appropriate ultrasonic data. Thus, the drive signal provides a power supply for the ultrasonic transducer.
[0031] The ultrasonic transducer unit is configured to receive these drive signals from the interface unit. This does not require an additional power input connection.
[0032] The interface unit is configured to receive RF echo signal data from the ultrasonic transducer unit and process the RF echo signal data to acquire one or more ultrasonic images.
[0033] In this embodiment, the ultrasonic transducer does not necessarily perform beamforming of the acquired RF echo signals, and these signals are directly sent to the interface unit, and appropriate signal addition / synthesis is performed to acquire ultrasonic images. This helps to reduce the cost of the transducer because more expensive signal processing circuits are not required for such transducers.
[0034] According to a further set of embodiments, the ultrasonic interface unit is adapted to be communicably coupled to an ultrasonic sensing device including local driving means for generating a driving signal for driving ultrasonic transmission by the transducer of the ultrasonic sensing device, and the configuration function includes communicating with the ultrasonic sensing device to adjust the parameters of the locally generated driving signal to the ultrasonic sensing device. For example, the interface unit is configured to communicate with the control unit of the ultrasonic sensing device to adjust the parameters of the locally generated driving signal to the ultrasonic sensing device. The ultrasonic sensing device includes an ultrasonic transducer unit (e.g., an ultrasonic probe), and the local driving means of the ultrasonic sensing device is for generating a driving signal for driving ultrasonic transmission by the transducer provided in the transducer unit.
[0035] The interface unit issues a control command to, for example, adjust ultrasonic acquisition parameters (e.g., transmission or reception parameters) to the local transmission controller (control unit) of the ultrasonic device. The control unit communicates with the local driving means to cause adjustment of the acquisition parameters.
[0036] The interface unit is adapted to transmit control commands in the form of one or more data signals or data messages to the control unit of the ultrasonic sensing device. The control unit of the ultrasonic sensing device communicates with local driving means in order to cause an adjustment in ultrasonic acquisition parameters (e.g., transmission / reception signals) based on the received data signal or data message.
[0037] Accordingly, in these embodiments, the interface unit does not directly drive the ultrasonic transmission by the transducer of the ultrasonic device. Instead, it communicates with the local control means of the ultrasonic device to induce the device to adjust the operating parameters of the transducer, e.g., the acquisition parameters. In this case, the ultrasonic device comprises an ultrasonic system having dedicated local transmission / reception control means.
[0038] According to one possible set of embodiments, the interface unit a first mode in which the interface unit is configured to supply power to the ultrasonic sensing device to drive ultrasonic transmission by the ultrasonic transducer of the ultrasonic sensing device during use, and a second mode in which the ultrasonic interface unit is adapted to be communicably coupled to an ultrasonic sensing device comprising local driving means for generating a driving signal for driving ultrasonic transmission by the transducer of the ultrasonic sensing device, the configuration function including communicating with the ultrasonic sensing device to cause the ultrasonic sensing device to adjust the parameters of the locally generated driving signal. is selectively operable in each of the two modes.
[0039] In one or more embodiments, the ultrasonic interface unit further comprises a display unit for displaying at least one derived anatomical or physiological parameter and / or for displaying one or more ultrasonic images generated based on the acquired ultrasonic data. Thus, this provides a secondary display in addition to the display of the patient monitor unit, enabling at least one physiological or anatomical parameter derived and monitored to be directly displayed on this secondary display.
[0040] As described above, according to one or more embodiments, the interface unit is further configured to generate guidance information for guiding a user during positioning of an ultrasonic transducer unit or sensor of an ultrasonic device for a subject for acquiring ultrasonic data suitable for obtaining at least one physiological or anatomical parameter.
[0041] The interface unit is configured to generate an information output including the derived information, for example, for output to a display unit coupled to or couplable to the interface unit during use, or for output to a patient monitor, for example.
[0042] The guidance information is, for example, information for guiding a user during the accurate placement of an ultrasonic transducer unit or sensor for a subject for obtaining ultrasonic data of optimal quality for deriving one or more desired physiological or anatomical parameters. The interface unit analyzes the received ultrasonic data by one or more algorithms to evaluate the quality level of the data for deriving the parameter or measurement of interest.
[0043] The guidance information includes information for guiding the adjustment of the position of the ultrasonic transducer unit or sensor with respect to the body. The interface unit generates a display output for controlling the display unit to display the guidance information for adjusting the ultrasonic transducer unit or sensor position. This is, for example, graphical or visual guidance information.
[0044] In one set of embodiments, the ultrasonic sensing device further comprises a display unit, and the ultrasonic interface unit is adapted to communicate a display output to the ultrasonic sensing device to cause the display of the guidance information on the display unit of the ultrasonic sensing device.
[0045] In one set of embodiments, the ultrasonic sensing device comprises a display unit, and the ultrasonic interface unit is configured to communicate with the ultrasonic sensing device to cause the display on the display unit of at least one physiological or anatomical parameter derived by the ultrasonic interface unit.
[0046] The configuration function includes causing an adjustment in one or more operating parameters of the ultrasonic sensing device to configure the ultrasonic sensing device to acquire ultrasonic data suitable for the purpose of ultrasonic monitoring. The operating parameters include, for example, the acquisition settings of the ultrasonic transducer of the ultrasonic sensing device. These include, for example, the transmit / receive frequency of the transducer, the delay timing for transmission and reception by the transducer (e.g., for adjusting beamforming settings), the drive voltage of the transducer, and / or the drive pattern for the transducer (e.g., for adjusting beamforming). These additionally or alternatively include, for example, the transmit voltage, line density, beam width, 2D vs 3D acquisition mode, field of view size, and / or frame rate.
[0047] According to one or more embodiments, the ultrasonic data received from the ultrasonic sensing device includes ultrasonic image data. For example, this includes one or more ultrasonic images.
[0048] For example, the ultrasonic sensing device includes processing means for processing the received data so as to generate one or more ultrasonic images, and the ultrasonic data received from the ultrasonic sensing device in the interface unit includes image data.
[0049] As a non-limiting example, the ultrasonic sensing device comprises an ultrasonic imaging system comprising one or more ultrasonic scanners or transducer units for acquiring ultrasonic data, and in addition thereto, one or more processors for at least partially processing the data. These local processors process the ultrasonic data so as to generate, for example, one or more images and / or perform beamforming, for example, based on the delay-and-sum technique.
[0050] According to one or more embodiments, the ultrasonic interface unit is adapted to receive an input signal from the patient monitoring unit and is adapted to configure one or more operating parameters of the ultrasonic sensing device based on the input signal.
[0051] Thus, in this set of embodiments, the adjustment of the settings for ultrasonic acquisition (e.g., imaging) can be made based on an input provided from the patient monitoring unit. The patient monitoring unit transmits a feedback signal to the interface unit, for example, in response to detecting that a change in patient monitoring information (e.g., vital signs) has met a defined criterion, for example, detecting that it has met or exceeded a predefined threshold.
[0052] Additionally or alternatively, the interface unit is further configured to generate guidance information for guiding a user during positioning of an ultrasonic transducer unit of an ultrasonic sensing device for a subject to obtain ultrasonic data suitable for obtaining at least one physiological or anatomical parameter. The ultrasonic interface unit is adapted to receive an input signal from a patient monitoring unit, and the ultrasonic interface unit is adapted to configure the guidance information based on the input signal.
[0053] Thus, in this set of embodiments, the input signal additionally or alternatively triggers an adjustment by the user guidance interface unit. For example, this causes the generation of a guidance output that prompts the user to (re)acquire one or more imaging views for updated image acquisition. The guidance output provides guidance for positioning the transducer unit with respect to the subject.
[0054] According to one or more embodiments, the ultrasonic interface unit is further connectable, in use, to one or more medical sensors for measuring one or more physiological parameters, and the ultrasonic interface unit is configured to receive sensor data from the one or more medical sensors. The interface unit is configured to use the sensor data in combination with the ultrasonic data, for example, when deriving at least one physiological or anatomical parameter.
[0055] Additionally or alternatively, in some examples, the interface unit is configured to receive sensor data and / or physiological parameter data from a patient monitoring unit. For example, the patient monitoring unit collects this data via one or more communicatively coupled sensors and then transfers or communicates the data to the interface unit in use.
[0056] The interface unit is configured to use the received sensor data or parameter data in combination with ultrasonic data, for example, when deriving at least one physiological or anatomical parameter. In some embodiments, the interface unit displays an indicator of the sensor or parameter data received from the patient monitoring unit on an optional display unit, together with, for example, parameter data obtained using ultrasound.
[0057] According to one or more embodiments, the ultrasonic interface unit is configured to generate a control signal for controlling the display unit to display at least one derived anatomical or physiological parameter and / or one or more ultrasonic images generated based on the acquired ultrasonic data. Thus, in these embodiments, the interface unit is configured to control an external or auxiliary display to present the derived parameters and / or the generated images, and the display may or may not be part of the interface unit itself. For example, the interface unit is operably connectable to an external display unit during use.
[0058] The interface unit includes processing means for processing the received ultrasonic data to generate one or more ultrasonic images.
[0059] According to one or more embodiments, the ultrasonic interface unit is configured to control the display unit to display an ultrasonic image with one or more derived physiological or anatomical parameters superimposed thereon.
[0060] In certain embodiments, the ultrasonic interface unit is provided in combination with one or both of an ultrasonic sensing device and a patient monitoring unit to provide an ultrasonic system. There are various options for providing the ultrasonic system depending on which parts are included in the system and which parts are external and operably coupled to the system.
[0061] An embodiment in accordance with one aspect of the present invention is an ultrasonic sensing device, and an ultrasonic interface unit communicably coupled to the ultrasonic sensing device and according to any of the embodiments or configurations outlined above or described below, or as set forth in any claim of the present application to provide an ultrasonic system comprising the same.
[0062] In certain embodiments, the system further comprises a patient monitoring unit communicably coupled to one or more medical sensors for receiving medical sensor data. Alternatively, the interface unit is adapted to be coupled to the patient monitoring unit in use.
[0063] In one or more embodiments, the ultrasonic sensing device comprises a base station and the ultrasonic interface unit is integrated within the base station. For example, the interface unit is physically installed inside at least a portion of the base station housing. The base station comprises, for example, processing means for processing ultrasonic data obtained by one or more ultrasonic transducers to generate one or more ultrasonic images.
[0064] In some embodiments, the ultrasonic sensing device is a portable or mobile ultrasonic sensing device.
[0065] In certain embodiments, the ultrasonic sensing device comprises a trolley-mounted ultrasonic unit comprising a diagnostic ultrasonic system or unit, such as an ultrasonic transducer unit, processing means, a display, and a user input device (e.g., a keyboard and / or a pointing device).
[0066] An embodiment according to a further aspect of the invention is a patient monitoring unit communicably coupled to one or more medical sensors for receiving medical sensor data, an ultrasonic interface unit communicably coupled to the patient monitoring unit and according to any embodiment or embodiment form outlined above or described below, or according to any claim of the present application and provides an ultrasonic system comprising the same.
[0067] In certain embodiments, the system further comprises an ultrasonic sensing device. Alternatively, the interface unit is adapted to be coupled to the ultrasonic sensing device in use. In either case, in certain embodiments, the ultrasonic sensing device conforms to any of the embodiments discussed above.
[0068] In one or more embodiments, the patient monitoring unit comprises a base station and the ultrasonic interface unit is integrated within the base station, for example, physically installed within at least a part of the housing of such a base station. In an embodiment, the base station comprises processing means configured to receive medical sensor data.
[0069] An embodiment according to a further aspect of the invention is receiving, from an ultrasonic sensing device, acquired ultrasonic data representative of a subject and performing processing of the ultrasonic data to derive at least one physiological or anatomical parameter related to the subject, Generating a data output representing at least one derived physiological or anatomical parameter and communicating the data output to a patient monitoring unit; Performing a configuration function including communicating with an ultrasonic sensing device to cause adjustment of one or more operating parameters of the ultrasonic sensing device so as to configure the ultrasonic sensing device to obtain ultrasonic data suitable for monitoring at least one physiological or anatomical parameter; Providing a method of an ultrasonic interface having the above.
[0070] According to one or more embodiments, the method further includes generating guidance information for guiding a user during positioning of an ultrasonic transducer unit of the ultrasonic sensing device with respect to a subject for obtaining ultrasonic data suitable for determining at least one physiological or anatomical parameter, and generating a display output for use in controlling a display unit to display the guidance information for adjustment of the position of the ultrasonic transducer unit.
[0071] An embodiment according to a further aspect of the present invention provides a computer program product including code means configured to cause a processor to perform the method of the interface according to any of the embodiments outlined above or described below or recited in any of the claims of the present application when executed on the processor.
[0072] These and other aspects of the present invention will be apparent from and elucidated with reference to the embodiments described hereinafter.
[0073] For a better understanding of the present invention and to more clearly show how the present invention may be carried out, reference is made, by way of example only, to the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS
[0074]
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DETAILED DESCRIPTION OF THE INVENTION
[0075] The present invention will be described with reference to the drawings.
[0076] It should be understood that the detailed description and specific examples, while indicating exemplary embodiments of the apparatus, systems and methods, are intended for purposes of illustration only and are not intended to limit the scope of the present invention. The features, aspects, and advantages of the apparatus, systems, and methods of the present invention will be better understood from the following description, the appended claims, and the accompanying drawings. It should be understood that the drawings are merely schematic and are not drawn to scale. It should also be understood that the same reference numerals are used throughout the drawings to indicate the same or similar parts.
[0077] The present invention provides an interface unit for connecting between an ultrasonic sensing device and a patient monitor to provide an ultrasonic monitoring function of one or more physiological or anatomical parameters based on the processing of ultrasonic data. The interface unit includes means for processing ultrasonic data acquired to derive measurements of one or more physiological or anatomical parameters, and is configured to output the derived measurements to a combined patient monitor unit, for example, for display and / or rendering by the patient monitor.
[0078] The interface unit further includes a function for assisting in the configuration or setup of the ultrasonic sensing device for use in monitoring one or more desired physiological or anatomical parameters. This includes, for example, means for communicating with the ultrasonic sensing device to adjust one or more operating parameters of the device. This further includes means for generating user guidance information for guiding a user during the accurate placement of an ultrasonic transducer unit or sensor on a subject, for example, to acquire ultrasonic data of optimal quality for deriving one or more desired physiological or anatomical parameters. This guidance information includes information for guiding the adjustment of the position of the ultrasonic transducer unit or sensor on the body. The interface unit generates a display output for displaying the guidance information for adjusting the ultrasonic transducer unit or sensor position on a display unit.
[0079] FIG. 1 schematically shows an exemplary ultrasonic interface unit according to one or more embodiments. The interface unit 12 is shown in use as being coupled to an ultrasonic sensing device 14 and a patient monitoring unit 18. These components are each shown only in schematic form so as to illustrate the connection configuration to the interface unit 12.
[0080] As a non-limiting example, the ultrasonic sensing device 14 comprises an ultrasonic imaging system comprising one or more ultrasonic scanners or transducer units for acquiring ultrasonic data, and in addition one or more processors for at least partially processing the data. These local processors process the ultrasonic data, for example, to generate one or more images and / or perform receive beamforming, for example, based on the delay-and-sum technique. In other embodiments, the ultrasonic sensing device comprises simply a stand-alone ultrasonic sensor or ultrasonic transducer unit comprising one or more transducers.
[0081] As an example, the patient monitoring unit 18 is configured to be communicatively coupled to one or more clinical or medical sensors to receive medical sensor data from the sensors in use. As non-limiting examples, such sensors include a pulse rate sensor (e.g., a PPG sensor), a blood pressure sensor, a respiration sensor, a blood oxygen saturation sensor, and / or a body temperature sensor. The patient monitoring unit 18 includes a local display unit for displaying the results of the medical sensor data, for example, which displays, over time, the rendered values of the medical sensors in the form of a graph, for example, indicating the progression of the medical parameters measured by the sensors. This includes user input means for configuring the settings of the patient monitor. This is configured to receive and display sensor data regarding one subject or patient or multiple subjects or patients.
[0082] The ultrasonic interface unit 12 is configured to receive the acquired ultrasonic data representing the subject from the ultrasonic sensing device 14.
[0083] The acquired ultrasonic data transferred to the interface unit 12 is either "raw" RF ultrasonic data or at least partially post - processed data. As those skilled in the art will realize, in the field of ultrasonic diagnostic imaging, the acquired RF ultrasonic data undergoes a series of processing steps to synthesize the received RF signals, format and configure the data, and then derive information such as one or more images, or anatomical or physiological measurements or quantifications from the data. These steps include any one or more of beam addition of received signal channels, band - pass filtering, decimation, I and Q component separation, and / or harmonic signal separation that serves to separate linear and non - linear signals to enable identification of non - linear (higher harmonics of the fundamental frequency) echo signals returning from tissue and micro - bubbles. The steps also include additional signal enhancement such as speckle reduction, signal synthesis, and / or noise removal. Subsequently, the steps may also include scan conversion to convert the acquired ultrasonic data into visual image data.
[0084] The ultrasonic data received by the interface unit is data at any point along such a series of processing steps.
[0085] The ultrasonic interface 12 is configured to perform processing of the received ultrasonic data to derive at least one physiological or anatomical parameter related to the subject.
[0086] The ultrasonic interface 12 is further configured to generate a data output representing the at least one derived parameter and communicate the data output to the patient monitoring unit 18.
[0087] The ultrasonic interface unit 12 is preferably further configured to perform a configuration function including communicating with the ultrasonic sensing device 14 to cause adjustment of one or more operating parameters of the ultrasonic sensing device so as to acquire ultrasonic data suitable for monitoring physiological or anatomical parameters over time.
[0088] The operating parameters include, for example, acquisition settings of the ultrasonic transducer of the ultrasonic sensing device. These include, for example, the transmission / reception frequency of the transducer, the delay timing for transmission and reception by the transducer (e.g., for adjusting beamforming settings), the drive voltage of the transducer, and / or the drive pattern for the transducer (e.g., for adjusting beamforming). These additionally or alternatively include, for example, the transmission voltage, line density, beam width, 2D vs 3D acquisition mode, field of view size, and / or frame rate.
[0089] The interface unit 12 includes a memory in which a preferred set of one or more operating parameters for the ultrasonic sensing device is stored, and the interface unit is configured to read out the settings and apply them to the ultrasonic sensing device 14 in use. Various sets of settings are stored corresponding to the various physiological or anatomical parameters to be derived. Alternatively, a preferred set of one or more settings may be stored remotely from the interface unit, and the interface unit is configured to communicate, for example, with a remote server via, for example, the Internet or a network connection to read out the settings.
[0090] This configuration function enables the interface unit to be used with any ultrasonic sensing or imaging unit by configuring the settings of the ultrasonic acquisition function to ensure that the collected ultrasonic data is optimal for deriving at least one physiological or anatomical parameter.
[0091] The interface unit 12 comprises one or more processors for performing any one or more of the functions outlined above.
[0092] In an advantageous embodiment, the interface unit 12 further comprises a display unit 24 operatively coupled to the interface unit. An example of such an embodiment is schematically illustrated in FIG. 2. The interface unit is configured to control the display unit to display the results of at least one derived anatomical or physiological parameter. The display unit is additionally or alternatively used to display one or more ultrasound images derived from the acquired ultrasound data. In an embodiment, such images are derived by the interface unit 12 or by appropriate processing means of the ultrasound sensing device 14.
[0093] In some embodiments, the interface unit 12 is configured to display the results of one or more derived physiological parameters on the display unit 24 as an overlay on the generated ultrasound image or volume. As an example, if the ultrasound data received by the interface unit includes image data, the results of one or more parameter quantifications are drawn over or adjacent to the ultrasound image used to derive the measurements.
[0094] As discussed, the ultrasound interface unit 12 is configured to process the received ultrasound data to obtain one or more physiological or anatomical parameters related to the subject. This process is also referred to in the present disclosure by the alternative name of measurement quantification.
[0095] Using ultrasonic data to derive physiological or anatomical parameter measurements is a known concept. As an example, an exemplary technique for processing ultrasonic data to extract such measurements is outlined in "Three-dimensional echocardiographic quantification of the left-heart chambers using an automated adaptive analytics algorithm: multicentre validation study" by Diego Medvedofsky et al., European Heart Journal-Cardiovascular Imaging, Volume 19, Issue 1, January 2018, pages 47-58.
[0096] As a non-limiting example, in an embodiment, physiological or anatomical parameters derived from ultrasonic data by an interface unit include one or more of left ventricle / right ventricle volume or external dimensions, blood flow through one or more blood vessels, heart rate, respiratory rate, maximum lung volume, stroke volume, and cardiac output. Other parameters to be monitored include, for example, the position and / or shape of any one or more of the mitral valve, tricuspid valve, atrial and / or ventricular septum, and left atrium and / or right atrium. The interface unit performs, for example, any of tracking and / or segmentation of the mitral valve and / or tricuspid valve, tracking and / or analysis of the atrial and / or ventricular septum, and segmentation of the left atrium and / or right atrium.
[0097] The acquired ultrasonic data represents a specific anatomical region of a subject. This data can then be processed to extract quantitative measurements related to one or more anatomical entities in that region. For example, one or more frames of ultrasonic data representing the cardiac region at one or more corresponding time points are received. This can be processed to determine the external dimensions of clinically relevant parts of the heart, such as the left ventricle, at different time points. If the frames are captured over one or more complete cardiac cycles, for example, a measurement of the patient's cardiac output can be derived.
[0098] In some embodiments, the processing of ultrasonic data to derive one or more physiological or anatomical parameters can be performed using one or more appropriate algorithms. These can include, for example, one or more machine learning algorithms. The machine learning algorithms are trained with training data that includes various exemplary frames or sets of frames of ultrasonic data, which are labeled with the accurate corresponding measurements of the physiological or anatomical parameters or measurements of interest.
[0099] In other embodiments, segmentation is performed on the received ultrasonic data to derive at least one physiological or anatomical parameter. For example, the received ultrasonic data is ultrasonic image data, and a segmentation algorithm is applied to this data to extract the dimensions of one or more anatomical bodies or entities represented within the data. In advantageous embodiments, for example, model-based segmentation is applied.
[0100] In certain embodiments, the ultrasonic data is acquired by the ultrasonic sensing device 14 in the present progressive tense, continuously, or repeatedly, and is received in real time by the ultrasonic interface unit 12. The interface unit processes this data (e.g., also in real time), enabling the derivation of iterative or continuous measurements of one or more physiological or anatomical parameters over time. In this way, the monitoring of one or more physiological or anatomical parameters is achieved.
[0101] More generally, depending on the measurements to be derived, the received ultrasonic data can be processed in different ways. As an example, as described above, in some cases, for extracting and measuring specific anatomical or physiological parameters, segmentation based on AI or a model (anatomical tissue segmentation) is applied to the received data. In some embodiments, the blood flow pattern is additionally or alternatively quantified. In this case, for example, color flow analysis is performed to derive the flow velocity and optionally also the spatial differences of these flow velocities.
[0102] According to some embodiments, means are additionally provided to enable the user to perform manual measurements of specific anatomical or physiological features (e.g., valves or ventricular walls), for example, by calipers or other measurement tools on the screen. In some embodiments, the system comprises means for temporally reflecting this measurement value in future image frames.
[0103] In an advantageous embodiment, the interface unit 12 is further configured to generate guidance information for guiding the user during the positioning of the ultrasonic transducer unit or sensor of the ultrasonic device with respect to the subject for acquiring ultrasonic data suitable for determining at least one physiological or anatomical parameter. In this way, a smart probe positioning function is realized.
[0104] Guidance information is, for example, information for guiding a user during the accurate placement of an ultrasonic transducer unit or sensor on a subject in order to obtain ultrasonic data of optimal quality for deriving one or more desired physiological or anatomical parameters. The interface unit analyzes the received ultrasonic data by means of one or more algorithms in order to evaluate the quality level of the data for deriving parameters or measurements of interest.
[0105] The guidance information includes information for guiding the adjustment of the position of the ultrasonic transducer unit or sensor on the body. The interface unit generates a display output for controlling the display unit to display the guidance information for adjusting the position of the ultrasonic transducer unit or sensor. This is, for example, graphical or visual guidance information.
[0106] For example, the interface unit is configured to analyze the received ultrasonic data and determine user feedback or guidance for positioning the ultrasonic probe in an acceptable position to ensure sufficient quality of at least one physiological or anatomical parameter to be derived. For example, the user operates the ultrasonic probe and the interface unit provides real-time feedback regarding the quality reference value or measurement of the current ultrasonic image, for example via a coupled display unit. Alternatively, the system may actively guide the user to manipulate the probe position / pose in a particular way to achieve the correct view. This is based, for example, on specific detected view points captured within the data.
[0107] For example, if the parameter to be derived is related to the left ventricle of the heart, the interface unit detects whether the left ventricle is located within the ultrasonic view point, and if so, processes the received ultrasonic data by one or more algorithms configured to detect whether it is optimally centered within the view point. If not, guidance information is generated regarding how the ultrasonic sensor or transducer unit should be moved to capture data at a view point that better represents the anatomical body of interest (e.g., the left ventricle).
[0108] As an example, the generation of the guidance information is realized using image analysis and / or machine learning algorithms or techniques.
[0109] According to one or more embodiments, the interface unit includes one or more pre-stored (e.g., stored in local memory) algorithms or computer programs adapted to process the received ultrasonic data and generate guidance information for guiding the user based on the processing. In some embodiments, different algorithms or programs are stored for each of one or more possible anatomical or physiological parameters to be derived. In some embodiments, the interface unit is adapted to establish a communication channel with a remote server that stores one or more algorithms or programs for processing the ultrasonic data to generate output guidance information, and is adapted to read at least one of the algorithms or programs for use in generating the guidance information.
[0110] In some embodiments, the ultrasonic interface unit is configured to receive positioning data representing the relative or absolute position or movement of an ultrasonic sensor or transducer unit provided in the ultrasonic sensing device 14. The ultrasonic device 14 includes, for example, one or more motion sensors built therein to detect the motion and / or position of this sensor or transducer unit within the ultrasonic sensor or ultrasonic transducer unit of the device. In a particular embodiment, this motion and / or position data is communicated in real time to the ultrasonic interface unit 21 and used in conjunction with ultrasonic and / or vital sign data for use in deriving user guidance information and / or ultrasonic signal quality reference values.
[0111] As described above, the interface unit is adapted to generate a display output for controlling a display unit to display guidance information. In one set of advantageous embodiments, the ultrasonic sensing device further includes a display unit, and the ultrasonic interface unit is adapted to communicate the display output to the ultrasonic sensing device to cause the guidance information to be displayed on the display unit of the ultrasonic sensing device. Alternatively, the interface unit includes a local display unit, and the display output is communicated to the local display unit.
[0112] According to one or more embodiments, the ultrasonic interface unit is adapted to receive an input signal from a patient monitoring unit and is adapted to implement configuring the operating parameters of the ultrasonic sensing device based on the input signal.
[0113] Thus, in this set of embodiments, the adjustment of the ultrasound acquisition (e.g., imaging) settings can be performed based on inputs provided by a patient monitoring unit. The patient monitoring unit transmits a feedback signal to the interface unit in response to, for example, detecting a change in patient monitoring information (e.g., vital signs) that meets a defined criterion, e.g., detecting that the change has met or exceeded a predefined threshold.
[0114] Additionally or alternatively, the interface unit is further configured to generate guidance information for guiding a user during the positioning of the ultrasonic transducer unit of the ultrasonic sensing device for the subject to acquire ultrasonic data suitable for obtaining at least one physiological or anatomical parameter. The ultrasonic interface unit is adapted to receive an input signal from the patient monitoring unit, and the ultrasonic interface unit is adapted to configure the guidance information based on the input signal.
[0115] Thus, in this set of embodiments, the input signal additionally or alternatively triggers an adjustment by the user guidance interface unit. For example, this causes the generation of a guidance output that prompts the user to (re)acquire one or more imaging views for updated image acquisition. The guidance output provides guidance for positioning the transducer unit with respect to the subject.
[0116] The benefit of this embodiment is to enable the generation of a snapshot of the relevant (e.g., cardiac) anatomical tissue near the detection time of the change in one or more physiological parameters, thereby enabling the clinician to derive a better understanding of the cause of the change.
[0117] In an advantageous embodiment, the ultrasonic interface unit is further configured to receive non-ultrasound-based medical sensor data, e.g., vital sign data of the subject, and to use this data when determining one or more physiological or anatomical parameters.
[0118] For example, the ultrasonic interface unit can further be coupled to one or more medical sensors for measuring one or more physiological parameters during use, and the interface unit is configured to receive sensor data from the one or more sensors. Alternatively, the interface unit receives medical sensor data via the patient monitoring unit 18, and the patient monitoring unit is operably coupled to one or more medical sensors for receiving this medical sensor data.
[0119] As a non-limiting example, the one or more physiological parameters measured by the medical sensor include vital signs of the patient such as heart rate, respiratory rate, body temperature, blood pressure, and / or blood oxygen saturation (SpO2).
[0120] As an example, the vital sign data or other medical sensor data obtained and displayed on the patient monitoring unit 18 can be sampled by the ultrasonic interface unit 12 and used in deriving one or more physiological or anatomical parameters.
[0121] Medical sensor data is also used to facilitate additional or alternative functions. For example, in some embodiments, this is used as a criterion for triggering the acquisition of ultrasonic data. For example, the acquisition of ultrasonic data and the derivation of at least one physiological or anatomical parameter from this data are triggered only in response to reaching or exceeding a specific threshold level of one or more parameters monitored by the medical sensor. For example, the measurement of cardiac output is triggered only in response to measuring a decrease or increase in the heart rate to a certain amount or a specific absolute level.
[0122] When the ultrasonic interface unit 12 includes a coupled display unit 24, the interface unit is configured to display received medical sensor data on the display regardless of whether the data was received from an auxiliary medical sensor coupled to the interface unit 12 or received via the patient monitoring unit 18.
[0123] As an example, waveform and / or numerical medical sensor data from the patient monitoring unit 18 is replicated for display on the display 24 of the interface unit 12. In some embodiments, the interface unit serves as, for example, a convenient additional portable device (e.g., a clinician's handheld or mobile device) that can access patient monitor information.
[0124] According to one or more embodiments, a given patient monitoring unit 18 is paired with a given ultrasonic interface unit 12, and the two are communicatively coupled to each other. In some embodiments, to facilitate such pairing, short-range communication means are provided within the interface unit 12. For example, pairing with a given patient monitoring unit is triggered, for example, using a near-field communication (NFC) tag, in response to tapping / contact on the patient monitor, e.g., on the screen of the patient monitor. If the patient monitor is stationary and out of reach (e.g., mounted at a high position on a wall), an alternative NFC assignment is possible via a different device, e.g., a patient monitor peripheral pairing touchpad that is located closer to the ground and communicatively coupled to the patient monitor 18.
[0125] According to one or more embodiments, the ultrasonic interface unit 12 includes user input means for receiving user input commands. The interface unit is configured to adjust or configure one or more operation settings based on the received user input. By way of example, the interface unit is configured to utilize user input commands when implementing a configuration function to configure the operation parameters of the ultrasonic sensing device. For example, the interface unit permits input via user input means for a preferred operation parameter setting for the ultrasonic sensing device 14 and configures the ultrasonic sensing device accordingly. Examples of operation parameters include, by way of example, acquisition interval, scan location (e.g., the target location of beamforming steering), scan frequency, and the like. When there is no user input, as discussed above, the interface unit instead automatically determines the operation parameters for the ultrasonic sensing device based on, for example, stored default settings.
[0126] The user input is also used to set at least one physiological or anatomical parameter to be derived by the interface unit based on the received ultrasonic data.
[0127] The ultrasonic interface unit 12 is operable to derive any one or more of a range of different physiological or anatomical parameters from the received ultrasonic data. In some embodiments, the ultrasonic interface unit is adapted to configure which parameters are derived from the acquired data based on the received user input. In other embodiments, this is determined automatically, for example (as discussed above) based on data from other medical sensors, or based on time, or based on, for example, a patient's medical history.
[0128] According to one or more embodiments, the ultrasonic interface unit includes communication means for communicating with a further computer or system in order to export the derived value of at least one physiological or anatomical parameter. For example, the interface unit 12 is configured to output or export the derived physiological or anatomical parameter measurements to a cloud storage server or platform.
[0129] In some embodiments, deriving one or more anatomical or physiological parameters is based on the use of one or more machine learning algorithms or models. The interface unit 12 is configured to export the derived parameter measurements to a remote server for storage, such as a cloud server. Further, an algorithm training mechanism is also provided, and based on the stored parameter measurement results, training of one or more machine learning algorithms is performed. The updated algorithm or model is communicated to the interface unit 12 and applied by the interface unit for future parameter derivation. Such training of the algorithm or model is performed in a patient-specific manner, and for each patient, the algorithm is trained and updated based on the results of the patient's own measurements, and a dedicated algorithm is created for each patient.
[0130] There are various options regarding the physical configuration of the ultrasonic interface unit 12. Next, the various options are outlined. Any of the features, functions, and options discussed above may be applied to any of the various embodiments discussed below.
[0131] According to one set of embodiments, the ultrasonic interface unit 12 is provided as a separate stand-alone unit having connection ports for connecting to each of the ultrasonic sensing device 14 and the patient monitoring unit 18 in use. Thus, this provides a bridge between the ultrasonic sensing device 14 and the patient monitoring unit 18, effectively adding additional processing power to the patient monitor to enable the derivation and monitoring of physiological or anatomical parameters based on ultrasonic data. Thus, this enables the patient monitor to effectively use an existing ultrasonic sensing device as an additional patient monitoring input in addition to other medical sensors connected to the patient monitor.
[0132] In this case, the ultrasonic interface unit provides a retrofit function, enabling any existing patient monitoring unit 18 and ultrasonic sensing device 14 to be connected together and used by the interface unit 12 to effect ultrasonic monitoring of relevant parameters.
[0133] The interface unit 12 is configured to be connected to the ultrasonic sensing device 14 via a wired or wireless connection. The interface unit includes a wired or wireless connection port to facilitate this connection. The ultrasonic device sends ultrasonic data to the interface unit. The ultrasonic data includes, for example, an ultrasonic image or volume. The ultrasonic device has means for locally deriving one or more measurements from the acquired ultrasonic data. Optionally, in this case, the interface unit is further configured to receive from the ultrasonic device one or more such measurements calculated by the US device.
[0134] The interface unit 12 is configured to connect to a patient monitoring unit via a wired or wireless connection. In some embodiments, this is configured to connect via the facility's wireless LAN. The interface unit includes a wired or wireless connection port to facilitate this. The interface unit is configured to communicate physiological and / or anatomical parameter measurements derived by the interface unit. These are displayed on the screen of the patient monitor and / or stored or cached in the patient monitor. These are, for example, rendered on the display of the patient monitor, i.e., display changes in parameters over time.
[0135] There are various options for the ultrasonic sensing device 14.
[0136] An example of this is illustrated in FIG. 3. In this embodiment, the ultrasonic sensing device 14 comprises a stand-alone ultrasonic transducer unit 28 or sensor, e.g., a stand-alone probe, but does not comprise associated transducer driving means or signal processing means.
[0137] In this case, the ultrasonic interface unit 12 is configured to provide power supply to the ultrasonic device for use in powering the drive of the ultrasonic transducer. Thus, the interface unit acts as a power source for the ultrasonic device.
[0138] In an advantageous embodiment, the ultrasonic interface unit generates and outputs a drive signal for driving the ultrasonic transducer of the ultrasonic transducer unit 28. The drive signal directly supplies power to the vibration of the transducer. Thus, they carry the power for driving the transducer but also directly control the signal transmission. Thus, the interface provides both the power to the transducer of the ultrasonic sensing device and the control of the transducer of the ultrasonic sensing device.
[0139] Therefore, in this set of embodiments, the configuration functions implemented by the interface unit 12 include configuring the parameters of these generated drive signals.
[0140] In this case, the interface unit 12 is configured to receive RF ultrasonic data. The interface unit is configured to perform the processing of this data so as to derive post-processed data (e.g., scan-converted data and / or ultrasonic images). Therefore, the interface unit serves as an ultrasonic processing unit or an image forming processor.
[0141] As an example, the stand-alone ultrasonic transducer unit 28 comprises a USB ultrasonic probe designed to connect to an ultrasonic system via a USB connection. This probe acquires appropriate ultrasonic data for monitoring one or more physiological parameters and can be utilized by the interface unit to output these to the patient monitoring unit 18. The USB probe is, for example, directly plugged into an appropriate connector socket of the interface unit 12. Although USB is mentioned, the ultrasonic probe may alternatively be connected using any communication or communication standard (e.g., Ethernet, serial, parallel, or any other communication standard) via any means of connection, wired or wireless.
[0142] Although not shown in FIG. 3, preferably, the interface unit further comprises a combined display unit 24. Preferably, when the connected ultrasonic sensing device is a stand-alone ultrasonic transducer unit 28, this display unit can be used to display real-time ultrasonic data, such as generated ultrasonic image data, in order to assist the user in positioning and operating the ultrasonic transducer unit. Thus, the display unit effectively functions as a primary ultrasonic display, as seen in a wide range of ultrasonic diagnostic systems. The optional display is controlled to display US data and / or to display the results of at least one monitored physiological or anatomical parameter. The display is switched intermittently between these two, or in some embodiments, the measurement results are displayed superimposed on the generated ultrasonic image (as discussed above).
[0143] A further embodiment is illustrated in FIG. 4.
[0144] In this embodiment, the combined ultrasonic sensing device 14 is an ultrasonic system that includes one or more ultrasonic transducer units 28 and further includes local drive means 30 for generating drive signals for driving ultrasonic transmission by the transducers of the one or more ultrasonic transducer units 28. In this case, the configuration function includes communicating with the ultrasonic sensing device to adjust the parameters of the locally generated drive signals to the ultrasonic sensing device.
[0145] Thus, in this case, the ultrasonic interface unit 12 does not need to provide power supply to the ultrasonic sensing device 14, nor does it need to generate drive signals for driving the ultrasonic transducers of the ultrasonic sensing device 14. The interface unit generates control signals or commands for adjusting the operating parameters of signal transmission, such as frequency, signal intensity, beam steering direction, or any other parameter, to the processing means 30 of the ultrasonic sensing device.
[0146] The processing means 30 of the ultrasonic sensing device 14 includes means for post-processing the RF ultrasonic data received from one or more ultrasonic transducer units 28, for example, means for performing reception beamforming and / or for scan-converting the data to generate image data.
[0147] The processing means 30 is configured to process the ultrasonic data received from at least one transducer unit 30 so as to generate one or more ultrasonic images.
[0148] The ultrasonic device 14 includes a local display unit 32 for displaying the representation of the received ultrasonic data, for example, one or more generated ultrasonic images.
[0149] The ultrasonic device includes user input means for permitting the input of user input commands by the user in order to control the operation parameters of ultrasonic acquisition and / or to label the acquired ultrasonic data.
[0150] In FIG. 4, the processing unit 30 also implements the function of local driving means for supplying a driving signal to the ultrasonic transducer. However, this is not essential. There may be a separate processing unit with which the interface unit communicates, and there may be separate driving means communicably coupled to the control unit and adapted to generate a driving signal for driving the ultrasonic transducer.
[0151] The interface unit is adapted to transmit control commands in the form of one or more data signals or data messages to the control unit of the ultrasonic sensing device. The control unit of the ultrasonic sensing device communicates with local drive means to cause adjustments in ultrasonic acquisition parameters (e.g., transmit / receive signals) based on the received data signal or data message. The data message or signal includes instructions or requests indicating the required changes to one or more characteristics of ultrasonic data acquisition. These relate to characteristics of the acquired ultrasonic data such as the ultrasonic field of view, the depth level of the ultrasonic data, or the data acquisition mode (e.g., 2D / 3D, B-mode, C-mode), or to characteristics of the drive scheme used to drive the ultrasonic transducer by the local drive means.
[0152] According to one possible set of embodiments, the interface unit A first mode in which the interface unit is configured to supply power to the ultrasonic sensing device to drive ultrasonic transmission by the ultrasonic transducer of the ultrasonic sensing device during use, and A second mode in which the ultrasonic interface unit is adapted to be communicably coupled to an ultrasonic sensing device including local drive means for generating a drive signal for driving ultrasonic transmission by the transducer of the ultrasonic sensing device, the configuration function including communicating with the ultrasonic sensing device to cause the ultrasonic sensing device to adjust the parameters of the locally generated drive signal. Is selectively operable in either of the two modes.
[0153] Depending on which type of ultrasonic device is connected to the interface unit, an appropriate mode can be selected. The mode is automatically selected by the controller of the interface unit or, in some embodiments, is selected by the user using a user interface.
[0154] The ultrasonic device takes the form of a trolley cart mounted on casters or wheels, and the cart transports processing means 30 and an optional display 32.
[0155] FIG. 5 illustrates a further embodiment. Here, an ultrasonic system 40 is provided that includes an ultrasonic sensing device 14 according to any of the embodiments discussed above, an ultrasonic interface unit 12 according to any of the embodiments outlined above or described below, or according to any claim of the present application.
[0156] In this set of embodiments, the ultrasonic interface unit 12 is provided integrated as a component of the ultrasonic sensing device 14. However, this is merely one option and is not essential. These two units may be provided physically separately.
[0157] In an example, the ultrasonic device includes a base station, and the interface unit 12 is integrated into at least a part of the base station and is coupled to the base station, for example.
[0158] In the specific embodiment of FIG. 5, the ultrasonic sensing device 14 includes a trolley-type ultrasonic system as discussed above, and the ultrasonic system includes ultrasonic processing means 30 and one or more coupled ultrasonic transducer units 28 or sensors. The ultrasonic device 14 optionally further includes a display unit 32. However, this merely represents an example, and in other embodiments, the ultrasonic device may have a different structural configuration.
[0159] In the embodiment of FIG. 5, the ultrasonic interface unit 12 is provided in combination with the processing means 30 of the ultrasonic sensing device 14. In other embodiments, the interface unit is provided integrated within a common outer housing together with the processing means. In a further embodiment, the interface unit is provided as a removable module within the ultrasonic device, for example, a module inserted into a receiving slot.
[0160] The processing means 30 and the interface unit 12 are coupled via an external wired or wireless connection (e.g., LAN, HDMI®, USB or others), or are coupled via, for example, hidden integrated internal wiring.
[0161] In some embodiments, the display unit 32 of the ultrasonic sensing device 14 is used to display the results of one or more physiological or anatomical parameters derived by the interface unit 12. A switch between a conventional US display (displaying the generated ultrasonic image) and a monitoring display (displaying physiological or anatomical parameters derived from the ultrasonic data) is realized.
[0162] In some embodiments, a secondary display (not shown) is provided to be communicably coupled to the interface unit 12, and the interface unit controls this secondary display to display the results of one or more physiological or anatomical parameters derived by the interface unit. This is an alternative to, or an addition to, displaying the results on the display of the patient monitoring unit 18.
[0163] In some embodiments, the interface unit 12 is not integrated with the ultrasonic device 14 and is instead provided spatially separated therefrom. A secondary display is provided physically attached to the ultrasonic device 14 and is communicatively coupled to the interface unit 12 to display the results of one or more physiological or anatomical parameters derived by the interface unit 12. The secondary display is realized, for example, as an additional display adjacent to the primary display 32 of the ultrasonic device (such a primary display is included as part of the device). For example, the secondary display is a swiveling display.
[0164] The interface unit 12 of the system 40 further comprises, in use, a connection port for connecting to the patient monitor 18. This is a wired or wireless connection port for making a wired or wireless connection. This connection enables the measurements derived by the interface unit to be communicated to the patient monitoring unit 18 and rendered on the display of the patient monitor.
[0165] FIG. 6 illustrates an example according to a further embodiment.
[0166] This set of embodiments comprises an ultrasonic system 42 comprising a patient monitoring unit 18 communicatively coupleable to one or more medical sensors for receiving medical sensor data and an ultrasonic interface unit 12 according to any of the examples or embodiments outlined above or described below or recited in any of the claims of this application.
[0167] In the example shown, the ultrasonic interface unit 12 is integrated as part of the patient monitoring unit 18. However, this is merely one option and is not essential. In other embodiments, these two units may be provided physically separate.
[0168] In some embodiments, the patient monitoring unit comprises a base station, and the interface unit is integrated within the housing of the base station.
[0169] The patient monitoring unit comprises a display for displaying sensor data received from one or more medical sensors that can be coupled to the patient monitoring unit 18 during use. In the illustrated embodiment, the patient monitoring unit comprises a small tablet-like device. However, in other embodiments, the patient monitor has a larger trolley-type configuration with a base station attached to a trolley cart, the trolley cart having casters or wheels that permit movement of the cart by the wheels. The patient monitor comprises a display and user input means.
[0170] In either case, the medical sensors are coupled to the patient monitor through a wired or wireless connection.
[0171] The interface unit 12 is coupled to the patient monitor through any suitable wired or wireless connection. This may be an external connection or, for example, through hidden integrated internal wiring.
[0172] The interface unit 12 is couplable to the ultrasonic sensing device 14 to receive ultrasonic data from the device during use. As discussed above, the ultrasonic data includes ultrasonic data at any point along a series of post-processing operations. In some embodiments, the ultrasonic data includes generated ultrasonic images. In some embodiments, the ultrasonic device is configured to locally derive one or more measurements and communicate these measurements to the interface unit 12.
[0173] In a preferred embodiment, a secondary display unit (not shown) is provided to be coupled to the interface unit, and the interface unit is configured to control the display unit to display the result of one or more physiological measurements derived (as discussed above). As an example, these results are displayed superimposed on the generated ultrasonic image. For example, one or more segmented maps of anatomical bodies are displayed superimposed on the ultrasonic image of the relevant anatomical region.
[0174] In some embodiments, the interface unit 12 is not integrated with the patient monitoring unit 18 and is instead provided to be spatially separated. The secondary display is provided physically attached to the patient monitoring unit and is communicatively coupled to the interface unit 12 to display the result of one or more physiological or anatomical parameters derived by the interface unit 12. The secondary display is realized, for example, as an additional display adjacent to the primary display of the patient monitoring unit. For example, the secondary display is a rotatable display.
[0175] An embodiment according to a further aspect of the present invention is receiving, from an ultrasonic sensing device, acquired ultrasonic data representing a subject and performing data processing to derive at least one physiological or anatomical parameter related to the subject; generating a data output representing the derived parameter and communicating the data output to a patient monitoring unit; performing a configuration function including communicating with the ultrasonic sensing device to cause adjustment of one or more operating parameters of the ultrasonic sensing device so as to configure the ultrasonic sensing device to acquire ultrasonic data suitable for monitoring physiological or anatomical parameters and providing a method of an ultrasonic interface having the above.
[0176] According to one or more embodiments, the method further includes generating guidance information for guiding a user during positioning of an ultrasonic transducer unit of an ultrasonic sensing device with respect to a subject for obtaining ultrasonic data suitable for determining at least one physiological or anatomical parameter, and generating a display output for use in controlling a display unit to display the guidance information for adjusting the position of the ultrasonic transducer unit.
[0177] Options and details of embodiments regarding each of the above steps are understood and interpreted according to the explanations and descriptions provided above with respect to aspects of the device of the present invention (i.e., aspects of the ultrasonic interface).
[0178] Any of the examples, options, or features or details of embodiments described above with respect to aspects of the device of the present invention (with respect to the interface unit) are applicable to, combined with, or incorporated into aspects of the method of the present invention.
[0179] An example according to a further aspect of the present invention also provides a computer program product including code means configured to cause a processor to perform the method outlined above when executed on the processor.
[0180] As discussed above, various embodiments use one or more processors or processing means to perform data processing. The processor or processing means can be implemented in many ways by software and / or hardware to perform the various required functions. The processor typically uses one or more microprocessors programmed with software (e.g., microcode) to perform the required functions. The processor may be implemented as a combination of dedicated hardware for performing some functions and one or more programmed microprocessors and associated circuitry for performing other functions.
[0181] Examples of circuits used in various embodiments of the present disclosure include, but are not limited to, conventional microprocessors, application specific integrated circuits (ASICs), and field programmable gate arrays (FPGAs).
[0182] In various embodiments, the processor is associated with one or more storage media such as volatile and non-volatile computer memories such as RAM, PROM, EPROM, and EEPROM (registered trademark). The storage media is encoded by one or more programs that implement the functions required when executed on one or more processors and / or controllers. The various storage media may be fixed within the processor and / or controller or may be portable and one or more programs stored therein may be loaded into the processor.
[0183] Variations to the disclosed embodiments can be understood and effected by those skilled in the art in practicing the claimed invention, by considering the drawings, the present disclosure, and the appended claims. In the claims, the terms "comprising," "including," "having," and the like do not exclude other elements or steps, and the singular does not exclude the plural. A single processor or other unit may perform the functions of several items recited in the claims. The mere fact that certain means are recited in mutually different dependent claims does not indicate that a combination of these means cannot be used to advantage. If a computer program is discussed above, it may be stored / distributed on a suitable medium such as an optical storage medium or a solid state medium supplied together with or as part of other hardware, but may also be distributed in other forms, such as via the Internet or other wired or wireless remote communication systems. It is noted that if the term "adapted" is used in the claims or the description, the term "adapted" is intended to be equivalent to the term "configured." Any reference signs in the claims should not be construed as limiting the scope.
Claims
1. An ultrasonic interface unit that can be communicatively coupled to both an ultrasonic sensing device and a patient monitoring unit during use, wherein the ultrasonic interface unit, during use, Receives acquired ultrasonic data representing a subject from the ultrasonic sensing device and performs processing of the ultrasonic data to derive at least one physiological or anatomical parameter related to the subject; Generates a data output representing the derived at least one physiological or anatomical parameter and communicates the data output to the patient monitoring unit; Communicates with the ultrasonic sensing device to cause adjustment of one or more operating parameters of the ultrasonic sensing device to configure the ultrasonic sensing device to acquire ultrasonic data suitable for monitoring the at least one physiological or anatomical parameter over time, including performing a configuration function; In an ultrasonic interface unit that performs the above, The ultrasonic interface unit further generates guidance information for guiding a user during positioning of the ultrasonic transducer unit of the ultrasonic sensing device with respect to the subject for acquiring ultrasonic data suitable for determining the at least one physiological or anatomical parameter, based on an input signal from the patient monitoring unit, and the ultrasonic interface unit generates a display output used when controlling a display unit to display the guidance information for adjustment of the position of the ultrasonic transducer unit, characterized in that Ultrasonic interface unit.
2. The ultrasonic interface unit according to claim 1, which supplies power to the ultrasonic sensing device to drive ultrasonic transmission by the ultrasonic transducer of the ultrasonic sensing device during use.
3. The ultrasonic interface unit generates a drive signal for driving ultrasonic transmission by the one or more ultrasonic transducers of the ultrasonic transducer unit, and the configuration function includes configuring parameters of the drive signal. The ultrasonic interface unit according to claim 2.
4. The ultrasonic sensing device includes local driving means for generating a drive signal for driving ultrasonic transmission by a transducer provided in the ultrasonic transducer unit of the ultrasonic sensing device, and the configuration function includes communicating with the ultrasonic sensing device to adjust parameters of the locally generated drive signal to the ultrasonic sensing device. The ultrasonic interface unit according to claim 1.
5. The ultrasonic interface unit further includes a display unit for displaying the derived at least one anatomical or physiological parameter and / or for displaying one or more ultrasonic images generated based on the acquired ultrasonic data. The ultrasonic interface unit according to any one of claims 1 to 4.
6. The ultrasonic sensing device includes a display unit, and the ultrasonic interface unit communicates the display output to the ultrasonic sensing device to cause the display of the guidance information on the display unit of the ultrasonic sensing device. The ultrasonic interface unit according to any one of claims 1 to 5.
7. The ultrasonic sensing device includes a display unit, and the ultrasonic interface unit communicates with the ultrasonic sensing device to cause the display of the at least one physiological or anatomical parameter derived by the ultrasonic interface unit on the display unit. The ultrasonic interface unit according to any one of claims 1 to 6.
8. The ultrasonic interface unit according to any one of claims 1 to 7, which receives an input signal from the patient monitoring unit and configures the one or more operating parameters of the ultrasonic sensing device based on the input signal.
9. The ultrasonic interface unit according to any one of claims 1 to 8, which is further connectable to one or more medical sensors for measuring one or more physiological parameters during use, and the ultrasonic interface unit receives sensor data from the one or more medical sensors.
10. An ultrasonic sensing device, The ultrasonic interface unit according to any one of claims 1 to 9, which is communicably coupled to the ultrasonic sensing device, and An ultrasonic system comprising the same.
11. The ultrasonic system according to claim 10, wherein the ultrasonic sensing device comprises a base station having processing means for processing ultrasonic data acquired by one or more ultrasonic transducers to generate one or more ultrasonic images, and the ultrasonic interface unit is integrated within the base station.
12. A patient monitoring unit communicably connectable to one or more medical sensors for receiving medical sensor data, The ultrasonic interface unit according to any one of claims 1 to 9, which is communicably coupled to the patient monitoring unit, and An ultrasonic system comprising the same.
13. The ultrasonic system according to claim 12, wherein the patient monitoring unit comprises a base station having processing means for receiving the medical sensor data, and the ultrasonic interface unit is integrated within the base station.
14. Receiving, from an ultrasonic sensing device, acquired ultrasonic data representing a subject, and performing processing of the ultrasonic data to derive at least one physiological or anatomical parameter related to the subject; Generating a data output representing the derived at least one physiological or anatomical parameter, and communicating the data output to a patient monitoring unit; Communicating with the ultrasonic sensing device to cause adjustment of one or more operating parameters of the ultrasonic sensing device so as to configure the ultrasonic sensing device to acquire ultrasonic data suitable for monitoring the at least one physiological or anatomical parameter; In a method of an ultrasonic interface, comprising: Generating guidance information for guiding a user during positioning of an ultrasonic transducer unit of the ultrasonic sensing device with respect to the subject for acquiring ultrasonic data suitable for determining the at least one physiological or anatomical parameter, based on an input signal from the patient monitoring unit; Generating a display output for use in controlling a display unit to display the guidance information for adjustment of the position of the ultrasonic transducer unit; A method of an ultrasonic interface, characterized by comprising the above.
15. A computer program comprising code means for causing a processor to perform the method according to claim 14 when executed on the processor.
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