System and method for rotational ultrasonic focusing

Abstract

The present invention relates to a system and method for use in ultrasound imaging for the selective optimization of imaging parameters with respect to an anatomical region of interest. The system and method of the present invention provides selective adjustment of imaging parameters to achieve higher resolution and / or deeper penetration into tissue, thereby improving image quality and / or field of view in the selected region of interest. The system for providing selective image focusing comprises a console configured to be operably associated with and exchange data with an ultrasound imaging device.

Description

Technical Field

[0001] (Cross - Reference to Related Applications) This application claims the priority and benefit of U.S. Provisional Application No. 63 / 525,259, filed on July 6, 2023, the content of which is incorporated herein by reference in its entirety.

[0002] (Field of the Invention) The present invention generally relates to ultrasonic imaging, and more specifically, to systems and devices that provide rotational focusing for the selective optimization of imaging parameters related to an anatomical region of interest.

Background Art

[0003] (Background) Ultrasonic imaging is a medical imaging technique for imaging organs and soft tissues within the human body. Ultrasonic images are produced based on the reflection of high - frequency sound waves from body structures. The intensity (amplitude) of the sound signal, combined with the time required for the wave to travel through the body, provides the information necessary to produce an image.

[0004] Ultrasonic imaging can be useful for physicians to evaluate, diagnose, and treat various medical conditions. When making a diagnosis based on an ultrasound examination, the physician must rely on proper image quality, access to appropriate views, and adequate quantification of all relevant structures and flows.

[0005] For example, catheter-based intravascular ultrasound imaging techniques used within blood vessels (e.g., intravascular ultrasound (IVUS) or intracardiac echocardiography (ICE)) are generally performed using two-dimensional (2D) ultrasound imaging. In an IVUS / ICE imaging system, an ultrasound transducer assembly is attached to the distal end of a catheter. The catheter is carefully maneuvered through the patient's body to the area of ​​interest, such as within the coronary arteries (in the case of IVUS) or the right atrium (in the case of ICE). The transducer assembly transmits ultrasound waves and receives echoes from those waves. The received echoes are then converted into electrical signals and transmitted to a processing device, where the resulting ultrasound image of the area of ​​interest may be displayed.

[0006] Conventional 2D ultrasound imaging is widely used because it can dynamically display 2D images of the area of ​​interest in real time. 2D intravascular ultrasound is a standard procedure, but it requires the operator to have a grasp of the anatomical structure in front of them for navigation. This requires a high degree of dexterity when maneuvering the catheter image plane and visualizing the target structure for specific intervention use cases. Therefore, both the catheter and the imaging plane must be manipulated in parallel. 2D imaging is also limited to displaying only slices of anatomical structures.

[0007] Furthermore, in typical ultrasound systems configured to visualize internal body regions, dynamic forces are often employed, resulting in dynamic movement of the body region over time. These dynamic forces and movement make it difficult to stabilize the internal imaging device and generate consistent and accurate images, if imaging of the structure cannot be enabled in real time (e.g., >20 Hz). As a result, the captured images often lack the necessary quality required to prescribe appropriate treatment or therapy. Due to the dynamic forces and movement acting, internal real-time imaging is limited to small two-dimensional areas or three-dimensional volume regions, as described below.

[0008] 2D array transducers enable three-dimensional (3D) ultrasound imaging. 3D ultrasound imaging was developed to address the shortcomings of 2D ultrasound imaging and to help diagnosticians and interveners gain a complete understanding of spatial anatomical relationships. In particular, physicians can visualize arbitrary planes of the reconstructed 3D volume as well as panoramic views of the region of interest. Thus, 3D imaging can result in superior depiction and evaluation of target structures, such as volume assessment.

[0009] However, 3D imaging systems have drawbacks and limitations. For example, 3D imaging systems provide a view of the region of interest that is limited to a pyramidal volume (e.g., a trapezoidal sector angle when viewed either laterally or anteriorly from the catheter), which is further limited to a 90° × 60° arc opening with respect to advanced imaging catheters. Thus, while 2D array transducers enable 3D ultrasound imaging, difficult engineering trade-offs still exist between system complexity and achievable image quality. Therefore, although 3D ultrasound imaging offers significant potential for a wide range of clinical applications, its clinical impact is currently limited, partly because image quality is often inferior to 2D imaging using linear or phase array transducers. Complete imaging of the area around the catheter in a 360-degree field of view using selective focusing can overcome the limitations of 2D and 3D image quality described above, and thus enable clinical users to deliver better therapy. [Overview of the Initiative] [Means for solving the problem]

[0010] (summary) This invention recognizes the shortcomings of current ultrasound imaging systems, particularly those that use ultrasound probes for 3D imaging. In particular, current 2D and 3D ultrasound systems are limited in that they apply a single generalized beamforming and reconstruction approach to the entire volume before them. Consequently, such systems suffer from associated technical challenges that limit the imaging quality of specific anatomical regions of interest within a complete 360-degree view.

[0011] For example, due to processing constraints, current circumferential 3D ultrasound imaging utilizes a constant rotation speed and a constant emission rate, which ultimately results in a constant angular resolution around the circumference. Thus, while circumferential 3D ultrasound imaging allows for the acquisition of a rotationally symmetric imaging volume via a rotating transducer or 2D array electronic scanning, the angular resolution with respect to the entire volume depends, among other factors, on a constant emission rate and a constant rotation speed. Furthermore, in circumferential 3D ultrasound imaging via a rotating transducer, and also in 2D matrix array systems, the maximum transmitted / received emission rate is constrained by the electronic design, which, specifically with respect to matrix array transducers, often requires a direct microbeamforming step in the transducer to reduce the data rate to the system.

[0012] The system and method of the present invention solve such problems by providing live ultrasound imaging using a rotating transducer array or a 3D ultrasound transducer and selectively improving or adapting the imaging quality in a specific direction of the region of interest. In particular, the present invention recognizes that imaging specific anatomical structures positioned in a particular angular direction can be improved if imaging parameters can be selectively adjusted to vary the imaging quality. Therefore, the system and method of the present invention enable selective directional focusing, depth adjustment, and / or resolution imaging, thereby enabling selective optimization of imaging parameters with respect to the anatomical region of interest.

[0013] For example, the system and method of the present invention provides selective adjustment of imaging settings to achieve higher resolution and / or deeper imaging depth, ultimately improving imaging quality in an anatomical region of interest. Imaging an anatomical region of interest can benefit from higher angular resolution, deeper imaging depth, and / or it can be located deeper within the tissue; therefore, high-quality imaging is not possible without adjusting these and other parameters. Based on angular synchronization, the present invention provides dynamically fitting imaging parameters during a single rotation so that image quality and / or field of view are improved in a certain direction. Thus, improved imaging settings are possible with respect to a selected region of interest, while other areas around the circumference do not require these more demanding settings.

[0014] In non-limiting embodiments, the system of the present invention performs selective rotational focusing by changing the transmission / reception emission rate, changing the imaging depth, changing the plane wave opening angle and steering angle, changing the sampling rate with respect to the reception / transmission pulse shape and type, and changing the transmission / reception sequence, and the equivalent. The focal region is therefore freely selected and adapted in the system by adjusting the phase between the motor speed and the repeating emission pattern and / or by dynamically adjusting the transmission / reception pattern. For example, the motor position and emission sequence may be modified to control the direction of the focal region. When a non-rotating ultrasonic design, e.g., a 2D matrix array system or any other form of 3D ultrasonic system is used, emission and directional focusing, depth, and resolution can be fully controlled through electronic element activation and delay (electron beamforming).

[0015] Accordingly, the system and method of the present invention provide control over the orientation of the focal region by mechanical and non-mechanical means, using various methods, including emission rate and / or rotational speed, either alone or in combination, to provide live 3D ultrasound imaging with imaging quality selectively improved / adapted in a specific orientation of the region of interest.

[0016] In one aspect, the present invention discloses a system for providing selective image focusing. The system includes a console configured to be operably associated with and to exchange data with an ultrasonic imaging device. The console comprises a hardware processor coupled to non-transient computer-readable memory containing instructions executable by the processor. The instructions cause the console to define and adjust a set of parameters associated with the operation of the ultrasonic transducer unit of the ultrasonic imaging device in order to achieve imaging characteristics of one or more images captured via the ultrasonic imaging device with respect to a first selected region of interest. Adjusting the set of parameters provides directional focusing and / or imaging quality control in a second selected region of interest, such that imaging characteristics and / or image quality are optimized with respect to one or more directions in the second selected region of interest compared to the first selected region of interest.

[0017] In some embodiments, the parameters include plane wave or divergent wavefront characteristics. In particular, in some embodiments, the plane wave or divergent wave characteristics include at least one of the following: virtual source focus, distance, opening angle, steering angle, number of individual flashes, transmission / reception pattern, transmission emission rate, imaging depth, rotation speed, rotation position, and three-dimensional (3D) wave direction steering.

[0018] In some embodiments, the imaging characteristics are associated with at least one of the following: angular resolution, field of view, imaging depth, transmission / reception pattern, transmission emission rate, and plane wave opening angle.

[0019] In various embodiments, the console is configured to dynamically define and / or adjust a set of parameters. For example, in some embodiments, imaging characteristics are selected and adjusted by dynamically adapting the transmission / reception pattern in a first and / or second selected region of interest. Furthermore, the first and / or second selected region of interest is defined based on one or more anatomical features. In some embodiments, the set of parameters is dynamically adjusted by optimizing the imaging depth and imaging resolution to provide a focused view of the first and / or second selected region of interest. For example, in certain embodiments, the imaging resolution comprises one or more of depth, lateral resolution, and angular resolution.

[0020] In some embodiments, the system further includes an ultrasonic imaging device operably coupled to a console. The ultrasonic imaging device may include an ultrasonic transducer unit capable of 3D imaging.

[0021] The console further includes, in some embodiments, a controller for enabling the acquisition of plane wave or divergent wave acquired data across a 360-degree circumferential imaging area, such that a first and / or second selected area of ​​interest lies within the circumference encompassing the 360-degree imaging area. In various embodiments, the controller is capable of controlling a rotary motor operably coupled to the ultrasonic transducer unit, enabling continuous rotation or positioning of the ultrasonic transducer unit.

[0022] In some embodiments, the console is configured to dynamically define and adjust a set of parameters during a single rotation so that the imaging characteristics and / or image quality are optimized in a selected direction of the second selected area of ​​interest compared to the imaging characteristics and / or image quality within and outside the first selected area of ​​interest. In some embodiments, the console is configured to dynamically define and adjust a set of parameters so that the imaging characteristics and / or image quality are optimized over a continuous range of the region from the first selected area of ​​interest to the second selected area of ​​interest. The imaging characteristics and / or image quality are optimized over the range of the region from the first selected area of ​​interest to the second selected area of ​​interest via linear interpolation of the set of parameters.

[0023] In some embodiments, the console is further configured to synchronize the emission rate and emission direction of the ultrasonic transducer units. The emission direction may be defined through the rotational position of the array, or, in the context of a 2D flat / flexible array, through the electronic control of individual transducer areas. Furthermore, in some embodiments, the image characteristics within a second selected region of interest are tuned by dynamically adjusting the phase between at least the motor speed and emission rate of the ultrasonic transducer units.

[0024] In some embodiments, the console is configured to adjust the imaging depth of the ultrasonic transducer unit, thereby creating an asymmetric imaging volume around the circumference and selectively performing imaging in a particular direction.

[0025] In other embodiments, the console is configured to adjust the emission rate of the ultrasonic transducer unit, thereby achieving higher angular resolution in the selected area of ​​interest.

[0026] In certain embodiments, the console is configured to adjust the plane wave or diverging wavefront characteristics and steering angles of the ultrasonic transducer unit, thereby achieving a complex shape of the imaging volume in a selected region of interest.

[0027] In some embodiments, the rotational speed of the ultrasonic transducer unit is varied by mechanical changes in the ultrasonic transducer unit. For example, in some embodiments, the mechanical change introduces friction inside the ultrasonic transducer unit in one direction, slowing down the rotation of the ultrasonic transducer unit. In certain embodiments, the firing rate is varied to compensate for the friction present inside the ultrasonic transducer unit.

[0028] In another aspect, the present invention discloses a method for providing selective image focusing. The method includes providing a console operably associated with and configured to exchange data with an ultrasonic imaging device, defining a set of parameters associated with the operation of the ultrasonic transducer unit of the ultrasonic imaging device to achieve imaging characteristics of one or more images captured via the ultrasonic imaging device with respect to a first selected region of interest via the console, and adjusting the set of parameters via the console, wherein adjusting the set of parameters provides direction focusing and / or imaging quality control in a second selected region of interest such that the characteristics and / or image quality are optimized with respect to one or more directions in the second selected region of interest compared to the first selected region of interest.

[0029] In some embodiments of this method, the parameters comprise plane wave or divergent wavefront characteristics. In certain embodiments, the plane wave or divergent wave characteristics comprise at least one of the following: virtual source focus, distance, opening angle, steering angle, number of individual emission, transmission / reception pattern, transmission emission rate, imaging depth, rotation speed, rotation position, and three-dimensional wave direction steering. Furthermore, the imaging characteristics are associated with at least one of the following: angular resolution, field of view, imaging depth, transmission / reception pattern, transmission emission rate, and plane wave opening angle. In some embodiments of this method, the console is configured to dynamically define and / or adjust the set of parameters. For example, in some embodiments, the imaging characteristics are selected and adjusted by dynamically fitting the transmission / reception pattern in a first and / or second selected region of interest. Furthermore, in some embodiments of the method of the present invention, the first and / or second selected region of interest is defined based on one or more anatomical features. In some embodiments of this method, the set of parameters is dynamically adjusted by optimizing the imaging depth and imaging resolution to provide a focused view of the region of interest. In certain embodiments, the imaging resolution comprises one or more of the following: depth resolution, lateral resolution, and angular resolution.

[0030] In various embodiments, the method of the present invention further includes providing an ultrasonic imaging device operably coupled to a console, the ultrasonic imaging device comprising an ultrasonic transducer unit capable of 3D imaging. In certain embodiments, the console further comprises a controller for enabling the acquisition of plane wave or divergent wave acquisition data over a 360-degree circumferential imaging area, where a first and / or second selected area of ​​interest lies within the circumference encompassing the 360-degree imaging area. The controller is capable of controlling a bias voltage selectively applied to one or more of a plurality of first and / or second electrodes of the transducer, comprising an array of individual imaging elements, the bias voltage defining a voltage for a row or column connected to the electrodes, activating or deactivating imaging by the individual imaging elements within the row or column, and defining an angular imaging aperture.

[0031] In some embodiments of the method of the present invention, the controller is capable of controlling a rotary motor operably coupled to an ultrasonic transducer unit, enabling continuous rotation or positioning of the ultrasonic transducer unit. For example, in some embodiments, the console is configured to dynamically define and adjust a set of parameters during a single rotation so that the imaging characteristics and / or image quality are improved in a selected direction of the second selected area of ​​interest compared to the imaging characteristics and / or image quality outside the first selected area of ​​interest. In some embodiments, the console is configured to dynamically define and adjust a set of parameters so that the imaging characteristics and / or image quality are optimized over a continuous range of regions from the first selected area of ​​interest to the second selected area of ​​interest. For example, in some embodiments, the imaging characteristics and / or image quality are optimized over the range of regions from the first selected area of ​​interest to the second selected area of ​​interest via linear interpolation of the set of parameters.

[0032] In some embodiments of the method of the present invention, the console is further configured to synchronize the emission rate and emission direction of the ultrasonic transducer unit. The emission direction may be defined through the rotational position of the array, or, in the context of a 2D flat / flexible array, through the electronic control of individual transducer areas. In some embodiments, the image characteristics within a second selected region of interest are adjusted by dynamically adjusting the phase between at least the motor speed and emission rate of the ultrasonic transducer unit. In some embodiments, the console unit is configured to adjust the imaging depth of the ultrasonic transducer unit, thereby creating an asymmetric imaging volume around a circumference and selectively performing imaging in a certain direction. Furthermore, in some embodiments, the console unit is configured to adjust the emission rate of the ultrasonic transducer unit, thereby achieving higher angular resolution in a second selected region of interest. The console unit is configured to adjust the plane wave or divergent wavefront characteristics and steering angle of the ultrasonic transducer unit, thereby achieving complex shapes of the imaging volume in the region of interest.

[0033] In some embodiments of the method of the present invention, the rotational speed of the ultrasonic transducer unit is varied by a mechanical change in the ultrasonic transducer unit. For example, in some embodiments, the mechanical change introduces friction inside the ultrasonic transducer unit in one direction, thereby slowing down the rotation of the ultrasonic transducer unit. In certain embodiments, the emission rate is varied to compensate for the friction present inside the ultrasonic transducer unit. [Brief explanation of the drawing]

[0034] [Figure 1] Figures 1A and 1B are schematic illustrations of an exemplary ultrasound system for providing visualization and characterization of blood vessels within a patient, which may be used in combination with the device of the present invention.

[0035] [Figure 2]Figure 2 is a perspective view of an imaging catheter to which the device of the present invention may be attached.

[0036] [Figure 3] Figure 3 illustrates the system of the present invention according to one embodiment of the present invention.

[0037] [Figure 4] Figure 4 illustrates schematic diagrams of the physical sensitivity of imaging elements in the radial direction around a cylindrical array catheter in several embodiments of a cylindrical transducer array used in conjunction with the system of the present invention.

[0038] [Figure 5] Figure 5 illustrates an active radial opening with respect to the radial direction around a cylindrical imaging catheter, as used in some embodiments of the present invention.

[0039] [Figure 6] Figure 6 illustrates the change in the rate of fire within the region of interest.

[0040] [Figure 7] Figure 7 illustrates how to adjust the imaging depth within the region of interest according to one embodiment of the present invention.

[0041] [Figure 8] Figure 8 illustrates how the plane wave opening angle and steering angle within the region of interest are changed according to one embodiment of the present invention.

[0042] [Figure 9] Figure 9 further illustrates selective image focusing within a region of interest according to one embodiment of the present invention.

[0043] [Figure 10] Figure 10 illustrates an embodiment of bias row activation in the device of the present invention.

[0044] [Figure 11]Figure 11 is a block diagram of a method for providing selective imaging focus according to one embodiment of the present invention. [Modes for carrying out the invention]

[0045] (Detailed explanation) This invention recognizes the shortcomings of current systems using ultrasound probes for 3D imaging, namely the technical challenges that limit the imaging quality of specific anatomical regions of interest within a complete 360-degree view. Imaging anatomical regions of interest can benefit from higher angular resolution, deeper imaging depth, and / or anatomical regions may be located deeper within the tissue; therefore, high-quality imaging is not possible without adjusting these and other parameters. In particular, current 2D and 3D ultrasound systems do not provide means for selective directional focusing, depth adjustment, and / or resolution imaging; instead, they apply a single generalized beamforming and reconstruction approach to the entire volume before them.

[0046] The present invention recognizes that imaging specific anatomical structures positioned in particular angular directions can be improved when imaging parameters can be selectively adjusted to vary the imaging quality. Therefore, the systems and methods of the present invention use a rotating transducer array or a 3D ultrasound transducer to provide live ultrasound imaging and selectively improve or adapt the imaging quality in specific directions of the region of interest.

[0047] Specifically, the present invention provides for selectively adjusting imaging parameters to achieve, for example, higher resolution and / or deeper penetration into tissue and / or improved imaging quality in an anatomical area of ​​interest. Based on angular synchronization, the present invention provides for dynamically fitting imaging parameters during a single rotation so that imaging is optimized in a certain focal area. In non-limiting embodiments, the system of the present invention performs selective rotation focusing by changing one or more of the following: changing the transmission / reception emission rate, changing the imaging depth, changing the plane wave opening angle and steering angle, changing the sampling rate for the reception / transmission pulse shape and type, and changing the transmission / reception sequence. Thus, image quality and / or field of view are improved in the selected direction. As a result, optimized imaging settings are possible with respect to the selected area of ​​interest, while other areas around the circumference do not require these more demanding settings.

[0048] In general, as is commonly understood, ultrasound imaging (echocardiography) uses high-frequency sound waves to visualize the inside of the body. Because ultrasound images are captured in real time, these images can also show the movement of internal organs as well as fluid flow (e.g., blood flowing through blood vessels). In ultrasound imaging, the imaging device (i.e., transducer, probe, or transducer probe) is placed directly on the skin or inside a body opening (e.g., intravascular ultrasound, intravascular sonication, intracardiac echocardiography). The final quality of the image acquired through ultrasound scanning is limited by the technical specifications of the equipment, the propagation of ultrasound through the tissue being analyzed, and the method used to reconstruct the image.

[0049] (Ultrasound imaging system) The system and method of the present invention address the technical challenges of limiting the field of view and / or imaging quality of a specific anatomical region of interest within a complete 360-degree view.

[0050] As described in more detail below, in some embodiments, the present invention provides a system for selective imaging focusing for defining a set of parameters associated with the operation of the ultrasonic transducer unit of an ultrasonic imaging device in order to achieve imaging characteristics of one or more images captured via the ultrasonic imaging device with respect to a first selected region of interest. The system adjusts the set of parameters to provide directional focusing and / or imaging quality control in a second selected region of interest so that imaging characteristics and / or image quality are optimized with respect to one or more directions in the second selected region of interest compared to the first selected region of interest.

[0051] The systems and devices of the present invention may be manufactured and / or assembled using current approaches. The systems and devices of the method may be operably connected to an ultrasound system, with certain hardware and software for providing image reconstruction and imaging assembly control, as described, for example, in Hennersperger et al.'s International PCT Application No. PCT / IB2019 / 000963 (published as WO2020 / 044117), U.S. Patent Publication No. US2022-0287679A1, and U.S. Patent No. 11,382,599 (the contents of which are incorporated herein by reference as a whole).

[0052] Figures 1A and 1B are schematic illustrations of an exemplary ultrasound system / device 100 for providing visualization and characterization of blood vessels in a patient 12, for example, in combination with the systems and methods of the present invention. Generally, the ultrasound system / device 100 includes an imaging catheter 102 equipped with an imaging assembly 104, and an ultrasound console 106 to which the imaging catheter 102 is to be connected.

[0053] Figure 2 is a perspective view of an imaging catheter 102, which may be used in conjunction with this system. The catheter 102 may include a catheter body 108, including proximal and distal portions. An imaging assembly 104 may be provided, for example, generally to the distal portion defining the distal end of the imaging catheter 103. A handle 110 is operably associated with the catheter body 108, allowing an operator (i.e., a surgeon or other medical professional) to manipulate and advance the imaging assembly 104 and the catheter body 108 to a desired target site in the patient's blood vessel. The handle 110 may include user-operable inputs for controlling various features and functions of the imaging assembly 104. An interface member 112 may be provided to the distal portion of the catheter body 108. The interface member 112 generally provides a connection between the imaging catheter 102, including the imaging assembly 104 and the handle 110, and a console 106 for the transmission of signals between them. The connection may include, for example, at least one of wired and wireless connections.

[0054] (Selective image focusing) Circumferential 3D ultrasound imaging allows for the acquisition of rotationally symmetric imaging volumes via a rotating transducer or 2D array electronic scanning. However, the maximum transmission / reception emission rate is constrained by the electronic design. As a result, due to processing constraints, current circumferential 3D ultrasound imaging uses a constant rotation speed and constant emission rate, resulting in a constant angular resolution around the circumference.

[0055] For example, in circumferential 3D ultrasound imaging via a rotating transducer, and also in 2D matrix array systems, the maximum transmission / reception emission rate is constrained by the electronic design, which, specifically with respect to matrix array transducers, often requires a direct microbeamforming step in the transducer to reduce the data rate to the system. The maximum emission rate is also limited by the penetration depth. For example, due to the average speed of sound being 1,540 m / s, a round trip to a depth of 40 mm requires 50 microseconds (20 kHz emission). A round trip to a depth of 100 mm requires approximately 130 microseconds (7.6 kHz emission). Requiring the deepest penetration depth throughout the entire volume significantly limits the emission rate.

[0056] Furthermore, the resulting data rate depends on the received analog-to-digital (A2D) conversion, with deeper penetration resulting in more samples being required per emission channel (for example, 40 megasamples per second with sampling times of 50 microseconds for a depth of 40 mm and 130 microseconds for a depth of 100 mm results in 2,000 samples for 40 mm and 4,000 samples for 100 mm). This requires much higher data rates to be transmitted throughout the entire imaging and processing step. For applications where not all processing occurs directly linked to A2D conversion (e.g., distributed systems, catheter applications, software-defined imaging pipelines), this poses a significant challenge to system design for sustainable processing and transmission data rates.

[0057] These considerations are limiting factors in current 3D and 4D imaging systems with matrix array probes and cylindrical imaging systems. Consequently, in contrast to the present invention, current 2D and 3D ultrasound systems do not provide means for directional focusing optimized for a given area; instead, they apply a single generalized beamforming and reconstruction approach to the entire volume at hand.

[0058] The systems and methods disclosed herein enable the dynamic adaptation of relevant ultrasound imaging parameters to provide optimized imaging in a selected region of interest. The improved imaging may, for example, have improved resolution and / or depth, if required. Thus, the present invention avoids the limitations associated with applying a homogeneous pattern across the entire volume, namely, much higher data rates, longer firing sequences, and resource overhead for individual element control.

[0059] The present invention recognizes that specific anatomical structures may require deeper, or otherwise enhanced, imaging settings located within the tissue, which can be positioned in certain angular directions that would benefit from higher resolution and / or deeper imaging depth, while other areas around the circumference do not require such demanding settings. The present invention provides enhanced angular resolution in specific areas of interest by selectively varying, adjusting, and / or adapting available resources, i.e., parameters and settings. Because available resources are limited, the present invention provides selective variation of these resources to focus on important structures of interest. The systems and methods disclosed herein selectively enhance or adapt imaging parameters in specific directions of the area of ​​interest to provide optimized and / or enhanced live ultrasound imaging.

[0060] In one aspect, the present invention discloses a system for selective imaging focus.

[0061] Figure 3 illustrates a system 300 of the present invention according to one embodiment of the present invention. The system includes a console 301 configured to be operably associated with and exchange data with an ultrasound imaging device 100. The console may include a hardware processor 309 coupled to non-transient computer-readable memory 307. The non-transient computer-readable memory 307 may include instructions executable by the processor to cause the console to define and adjust parameters for ultrasound imaging in a selected region of interest. The console may include a computing system 305 such that the computing system causes the console to define and adjust a set of imaging parameters for the selected region of interest via memory.

[0062] As described in detail herein, the console defines a set of parameters associated with the operation of the ultrasonic transducer unit of the ultrasonic imaging device in order to achieve imaging characteristics of one or more images captured via the ultrasonic imaging device with respect to a first selected region of interest. The console then adjusts the set of parameters. Adjusting the parameters provides directional focusing and / or imaging quality control in the second selected region of interest so that the imaging characteristics and / or image quality are optimized with respect to one or more directions in the second selected region of interest compared to the first selected region of interest.

[0063] Therefore, the set of parameters is defined with respect to the overall volume and may then be adjusted to optimize imaging in a selected region of interest or focal region within the volume. The system allows for the definition of multiple regions of interest by selectively fitting imaging parameters to achieve one or more desired imaging characteristics in the region of interest. The system may define a region of interest as an overall image, or define a region of interest or multiple regions of interest within a complete image, and selectively optimize imaging within the defined regions. This allows for the definition of multiple regions of interest, for example, one region being a complete image and one or more others being certain focal regions. Thus, the system and method of the present invention provide optimized imaging in the focal region compared to the overall volume, e.g., improved imaging contrast, resolution, sensitivity, and / or depth.

[0064] This system defines a set of parameters associated with the operation of the ultrasonic transducer unit of an ultrasonic imaging device in order to achieve imaging characteristics of one or more images captured via the ultrasonic imaging device. The imaging device may be, for example, a rotational transducer array or a 3D ultrasonic transducer. Thus, this concept may also be applied to 3D circumferential rotational imaging and 2D matrix array imaging systems, both of which may be specifically optimized to provide a focused view of a desired target region / anatomical structure, while full volumetric information is available to provide the user with an enhanced anatomical context.

[0065] In some embodiments, the parameters include plane wave or divergent wavefront characteristics. For example, in non-limiting embodiments, the plane wave or divergent wave characteristics may be at least one of the following: virtual source focus, distance, opening angle, steering angle, number of individual flashes, transmission / reception pattern, transmission emission rate, imaging depth, rotation speed, rotation position, and three-dimensional (3D) wave direction steering.

[0066] Ultrafast ultrasound imaging techniques, such as plane wave or divergent wave imaging, may be required to enable imaging, particularly within the constraints of applications for intravascular and / or intracardiac tissue imaging. The systems and methods of the present invention enable the direct use of all inherent ultrafast imaging techniques. For example, in relation to intracardiac imaging, plane wave imaging may refer to an ultrasound imaging modality in which a plane wavefront can traverse tissue and be partially scattered back to the transducer through the flat transmission of all transducer elements (at different angles) from an angular imaging aperture. From the received radio frequency (RF) (i.e., channel) data, the overall image can be reconstructed simultaneously and in parallel by dynamically beamforming the RF data received for each target location.

[0067] In the present invention, the transducer may be of any type for transmitting and receiving acoustic waves. For example, the transducer may include a one- or two-dimensional array of electronic transducer elements for transmitting and receiving acoustic waves. These arrays may include micro-electromechanical system (MEMS) based transducers such as capacitive micromachined ultrasonic transducers (CMUTs) and / or piezoelectric micromachined ultrasonic transducers (PMUTs).

[0068] CMUT devices offer superior bandwidth and acoustic impedance characteristics, making these transducers preferable to conventional piezoelectric transducers. Vibration of the CMUT film can be triggered by applying pressure (e.g., using ultrasound) or electrically induced. Often, electrical connections to the CMUT device, such as integrated circuits (ICs) like ASICs, facilitate both the transmission and reception modes of the device. In reception mode, changes in film position cause changes in electrical capacitance, which can be electronically detected during transmission mode; applying an electrical signal causes vibration of the film.

[0069] Piezoelectric micromachined ultrasonic transducers (PMUTs) are based on the flexural motion of a thin film coupled with a thin piezoelectric film such as PVDF. This is in contrast to bulk piezoelectric transducers, which use the thickness mode motion of a piezoelectric ceramic plate such as PZT or single-crystal PMN-PT. Compared to bulk piezoelectric ultrasonic transducers, PMUT devices offer advantages such as increased bandwidth, flexible geometry, natural acoustic impedance matched with water, reduced voltage requirements, and especially the mixing of different resonant frequencies and potentials for integration with supporting electronic circuits for miniaturization and high-frequency applications. Current PMUT devices do not require bias to achieve imaging sensitivity.

[0070] The transducer may be a micro-electromechanical system (MEMS) based capacitive micromachined ultrasonic transducer (CMUT) configured as a two-dimensional (2D) array structure. In non-limiting embodiments, the 2D array may be a flexible structure. The cylindrical imaging array may consist of a flexible 2D array structure in the CMUT design. Flexible MEMS-based arrays may be implemented by wafer thinning (CMUT / PMUT), as described, for example, in Mimoun, 2013, "A generic platform for the fabrication and assembly of flexible sensors for minimally invasive instruments," IEEE Sensors J 13(10) 3873-3882 (incorporated herein by reference), or by using specific approaches such as combining a rigid imaging cell with a flexible interconnect.

[0071] In addition, and / or alternatively, transducers may be fabricated from electrostrictive materials, configured as a two-dimensional (2D) array structure. Electrostriction is a property of all dielectric materials and consists of mechanical displacement as a response to an electronic field, such as material compression in a region of high electric field intensity. In electrostriction, the electric field applied to a material causes deformation of the material (direct effect), and the mechanical stress applied to the material changes the polarization of the material (inverse effect). Transducers may be fabricated from electrostrictive materials such as electrostrictive polymers, or any material that can be activated using a bias voltage to achieve imaging sensitivity.

[0072] As described herein, the system defines a set of parameters associated with the operation of the ultrasonic transducer unit of an ultrasonic imaging device. The parameters may be associated with plane wave or divergent wave characteristics. As described in detail herein, the plane wave or divergent wave characteristics may be, for example, virtual source focus, distance, opening angle, steering angle, number of individual flashes, transmission / reception pattern, transmission emission rate, imaging depth, rotation speed, rotation position, and three-dimensional (3D) wave direction steering.

[0073] In this context, a virtual source focus includes a method of coherently combining recorded data from multiple transmissions to form a composite focus that makes geometric assumptions about the transmissions. These also include divergent waves (virtual sources behind the array) and plane waves (virtual sources at infinity). Furthermore, the steering angle is not limited to a specific direction, but rather encompasses both lateral and elevation steering angles. To avoid bias due to the word "angle," steering angle is understood to mean steering in 3D.

[0074] Figure 4 illustrates schematic diagrams of the physical sensitivity of imaging elements in the radial direction around a cylindrical array catheter in several embodiments of a cylindrical transducer array. The cylindrical shape (or radius of the cylinder) provides a geometric boundary constraint to which elements can receive data about points in space relative to it. With respect to the active elements, the physical sensitivity aperture of the elements is illustrated. Sensitivity is a key parameter for describing the electrical-transducer energy conversion efficiency and is an important indicator of transducer performance. Generally, sensitivity is defined as the ratio of the output to the input.

[0075] An aperture is the active area that transmits or receives acoustic waves at a given moment. For a single-element transducer, the aperture size is the size of the transducer element. For a transducer with an array of elements, the aperture is all the elements that are active simultaneously. Generally, as is understood, ultrasound imaging has spatial heterogeneity resolution that depends on the size of the transducer's active aperture (including the dimensions of each ultrasound element), the transducer's center frequency and bandwidth, and the selected transmission pattern. For focused imaging, the lateral resolution is best at the focal length and widens in a non-uniform manner away from this distance due to diffraction effects caused by apertures of approximately several to tens of wavelengths. For non-focused imaging such as plane wave or divergent wave imaging, the lateral resolution for transmission widens away from the transducer surface because focusing is performed using multiple transmission waves.

[0076] Figure 5 illustrates an active radial aperture for radial projection around a cylindrical imaging catheter, used in some embodiments of the present invention. The active aperture depends on the angular coverage of each physical element (i.e., the directivity of the imaging element). Each ultrasonic transducer has its own specific directivity pattern. The directivity pattern, also known as the beam pattern or radiation pattern, is an important far-field characteristic of the transducer. The directivity pattern consists of a main lobe and side lobes. The radiation intensity is predominantly in the frontal region of the transducer source; therefore, the main lobe is directly in front of the ultrasonic transmitter, followed laterally by side lobes, with a null region between these lobes. In general, the directivity pattern is the same whether the transducer is used as a transmitter or a receiver. The system of the present invention may use a flexible imaging array system, for example, one that allows matrix addressing in combination with bias activation, to allow flexibility in convex aperture selection and optimization.

[0077] Flexible imaging arrays for ultrafast ultrasonic imaging may be configured for any shape, e.g., cylindrical / non-cylindrical, flat, and non-flat. Flexible arrays can enable the definition and optimization of angular apertures for surfaces of any shape, particularly concave surfaces, e.g., for cylindrical arrays.

[0078] It should be noted that the specific description of the present invention includes the use of the system of the present invention for ultrasound visualization of intravascular and / or intracardiac tissues, which may be particularly useful for catheter-based interventional procedures for assessing anatomical and functional data in relation to a target volume of interest. However, as is generally understood, the system and method of the present invention may be used for ultrasound visualization of any type of tissue in relation to any type of procedure in which imaging analysis is used and / or preferred.

[0079] In some embodiments, the imaging characteristics are associated with at least one of the following: angular resolution, field of view, imaging depth, transmission / reception pattern, transmission emission rate, and plane wave opening angle.

[0080] For example, the system may first synchronize the current angular direction and then dynamically adapt other imaging parameters to achieve improved imaging. Based on the angular direction synchronization, the imaging parameters may be dynamically adapted during a single rotation / volume process so that the image quality and / or field of view are improved in a certain direction, and thus imaging achieves the desired optimization.

[0081] As disclosed herein, the console may be configured to dynamically define and / or adjust a set of parameters. Thus, the parameters may be adjusted during the image acquisition process, for example, during the process of one or more rotations.

[0082] Selective image focusing may be achieved in several different ways. For example, firstly by achieving synchronization between the emission and rotational position. Subsequently, selective improvement of image quality or field of view in a particular direction may be achieved by configuring a specific ultrasonic emission pattern. The phase between the motor position and the emission sequence may be modified to control the direction of the "focus region". When a non-rotating ultrasonic design is used (e.g., in a 2D matrix array system or any other form of 3D ultrasonic system), emission and directional focusing / depth / resolution can be fully controlled through electronic element activation and delay (electron beamforming).

[0083] Figure 6 illustrates, for example, changing the emission rate within a region of interest by applying a higher emission rate within that region. A higher emission rate allows for more beams and therefore higher resolution in the target tissue. In some embodiments, imaging characteristics are selected and adjusted by dynamically adapting the transmission / reception pattern in a first and / or second selected region of interest. As an example, the transmission / reception emission rate may be adapted or modified to achieve a higher angular resolution in a selected direction. Specifically, the emission rate may be increased within a selected region of interest during the rotation process to achieve a higher angular resolution within that region. Thus, the emission rate can be associated with the density of emission in a given region. Therefore, the emission rate may be higher in density compared to the density of emission in the rest of the rotation volume.

[0084] The imaging system is fundamentally limited by the ballistic time it takes for ultrasound to reach / reflect within the tissue, e.g., 1,540 m / sec for soft tissue. The system is limited to transmitting / receiving on only a portion of the full 2D array, or, if using a rotating array concept, the transmission / reception area is limited by the rotation of the array. Therefore, to maximize the emission density in one region, the overall volume imaging rate, i.e., the imaging rate over the entire rotation, may need to be reduced (e.g., imaging at 10 Hz only instead of 20 Hz), or the emission density or penetration depth may be reduced in a given region. Thus, the system allows for the selective modification of these parameters when applied to full-rotation imaging, and selective optimization of imaging within the volume of the region of interest.

[0085] As disclosed herein, the system provides continuous fitting of imaging parameters. For example, there may be one or more distinctly different imaging parameters or qualities defined by the system with respect to the inside and outside of the region of interest, but the system also enables continuous blending of parameters instead of discrete parameter sets for distinctly different regions. Thus, the system enables a change from discrete parameter definitions to continuous fitting of parameters in the region of interest, and provides continuous blending of imaging.

[0086] As discussed in detail above, the system may include an ultrasonic imaging device operably coupled to the console. The ultrasonic imaging device may include an ultrasonic transducer unit capable of 3D imaging. In some embodiments, the console further includes a controller for enabling the acquisition of plane wave or divergent wave acquired data over a 360-degree circumferential imaging area, where the first and / or second selected area of ​​interest lies within the circumference encompassing the 360-degree imaging area.

[0087] Furthermore, the system may use a bias voltage to adjust the frequency range of the imaging array within the region of interest, and the sensitivity for the frequency range is driven by the bias voltage. The bias voltage may also be used to completely deactivate imaging elements in the region of interest or within the volume as a whole. Importantly, using a bias voltage to activate imaging elements (i.e., cells) enables imaging without multiplexing. Bias activation means that when a nominal bias voltage is applied and the imaging array is adjusted to the target center frequency, imaging will be activated on the row or column in question. Similarly, applying a bias voltage of 0V or a voltage level at which the sensitivity of the imaging element is minimal will deactivate the imaging row or column. This allows for the activation or deactivation of entire rows or columns on the array and provides the ability to employ a flexible transmission / reception scheme on rows and / or columns that are activated with respect to electron focusing.

[0088] In some embodiments, the controller can control a rotary motor operably coupled to the ultrasonic transducer unit, enabling continuous rotation or positioning of the ultrasonic transducer unit.

[0089] In some embodiments, the console may be configured to dynamically define and adjust a set of parameters during a single rotation process so that the imaging characteristics and / or image quality are optimized in a selected direction of a second selected area of ​​interest compared to the imaging characteristics and / or image quality within and outside a first selected area of ​​interest.

[0090] Furthermore, in some embodiments, the console is configured to dynamically define and adjust a set of parameters so that the imaging characteristics and / or image quality are optimized over a continuous range of regions from a first selected region of interest to a second selected region of interest. The imaging characteristics and / or image quality may be optimized, for example, by linear interpolation of the set of parameters over the range of regions from the first selected region of interest to the second selected region of interest.

[0091] As described above, in some embodiments, the console is further configured to synchronize the emission rate and emission direction of the ultrasonic transducer units. The emission direction may be defined through the rotational position of the array, or, in the context of a 2D flat / flexible array, through the electronic control of individual transducer areas. The image characteristics within a second selected region of interest may be adjusted by dynamically adjusting the phase between at least the motor speed and emission rate of the ultrasonic transducer units.

[0092] In some embodiments, the set of parameters may be dynamically adjusted by optimizing the imaging depth and imaging resolution to provide a focused view of a first and / or second selected region of interest.

[0093] Figure 7 illustrates the adaptation of the imaging depth within a region of interest according to one embodiment of the present invention. Varying the imaging depth may allow for the creation of an asymmetric imaging volume around the circumference to selectively image deeper structures in a particular direction. The imaging depth may be kept constant in other directions where imaging of deeper tissues is not important. This concept may also be applied to electron focusing / multiplexing and mechanical rotation. In some embodiments, the imaging resolution includes one or more of depth, lateral resolution, and angular resolution.

[0094] In some embodiments of the system of the present invention, the console is configured to adjust the imaging depth of the ultrasonic transducer unit, thereby creating an asymmetric imaging volume around the circumference and selectively performing imaging in a particular direction. As disclosed herein, the console may also be configured to adjust the emission rate of the ultrasonic transducer unit, thereby achieving higher angular resolution in a selected region of interest.

[0095] Furthermore, the console may be configured to adjust the plane-wave or divergent wavefront characteristics and steering angle of the ultrasonic transducer unit, thereby achieving complex shapes of the imaging volume in the selected region of interest.

[0096] Figure 8 illustrates the variation of the plane wave opening angle and steering angle within the region of interest according to one embodiment of the present invention. Varying the plane wave opening angle and steering angle results in a complex shape of the imaging volume that can be adapted to image a certain volume of interest. For example, in one direction, the plane wave may extend at a wide angle to achieve a wide opening angle in that direction, while having a narrow-angle configuration in the other direction to achieve higher imaging quality in that direction. This can be useful in intracardiac imaging when the intracardiac imaging catheter is placed in the right atrium and selectively provides deeper imaging with higher resolution in the septal region. With respect to more lateral regions of the placement, such as the lungs, deeper penetration would not be required in terms of anatomical context.

[0097] Figure 9 further illustrates selective image focusing within a region of interest according to one embodiment of the present invention. Selective image focusing can be achieved by configuring a specific ultrasonic emission pattern, provided that good synchronization between the emission and rotational position is achieved. The phase between the motor position and the emission sequence may be modified to control the direction of the “focus region”. When a non-rotating ultrasonic design is used (e.g., in a 2D matrix array system or any other form of 3D ultrasonic system), emission and directional focusing / depth / resolution can be fully controlled through electronic element activation and delay (electron beamforming).

[0098] In some embodiments, the present invention provides mechanical solutions for non-uniform rotational speed and firing rate. For example, instead of varying the firing rate, the rotational speed may be varied by mechanical changes in the catheter, introducing friction inside the catheter in one direction. In some embodiments, the rotational speed of the ultrasonic transducer unit is varied by mechanical changes in the ultrasonic transducer unit.

[0099] Figure 10 illustrates one embodiment of a rotational transducer 500 with a non-circular outer portion 501 and a static outer catheter 503. With respect to a rotational transducer with a constant firing rate, using a mechanical change to slow down the rotation of the transducer results in more firing from the transducer element 505 in the region where the rotation is slowed down. By using a constant firing rate, this will result in more firing in that direction. For example, the mechanical change may be the area of ​​eccentricity 507 in the rotational transducer. The eccentricity may be the result of the addition of rubber or other material to produce friction in the rotation of the transducer, for example.

[0100] In some embodiments, a mechanical change introduces friction inside the ultrasonic transducer unit in one direction, slowing down the rotation of the ultrasonic transducer unit. However, the system also allows for compensating for the mechanical behavior when friction is present inside the transducer unit, so that it rotates more slowly in a certain region. Varying the emission rate in the region of interest or the volume as a whole compensates for this mechanical behavior. Therefore, in some embodiments, the emission rate is varied to compensate for the friction present inside the ultrasonic transducer unit. In some embodiments, the motor is non-discrete to change from one set of parameters to the next. In other embodiments of the system, the motor is a discrete function.

[0101] As described above, the selected region of focus may be based on a certain anatomical feature. In some embodiments, the first and / or second selected region of focus is defined based on one or more anatomical features, such as a specific ablation pathway. Thus, the selected region of focus or focus region may be defined based on the anatomical structure being imaged.

[0102] The system and method of the present invention provide software-controlled fitting of imaging parameters, for example, through software-controlled focus area steering. In any of the modifications, the focus area may be freely selected and fitted in software by fitting the phase between the motor speed and the repeating firing pattern, or by fitting the transmission / reception pattern. The fitting may be performed dynamically during imaging.

[0103] The orientation of the focal region may be controlled in several ways. For example, the focal region may be presented directly to the user by setting the angle of the focal region, for example, through a user interface element, such as direct control of the focal region angle, or by directly indicating a specific area of ​​interest in the image using the mouse. The focal region may be implicitly controlled and / or adapted in combination with 3D visualization of the data. Thus, the focal region will be implicitly linked to an area within the central focus of the 3D visualization. If the viewpoint of the 3D visualization changes, the imaging focal region will be automatically adapted. This also takes into account knowledge of areas that are not displayed at all (outside the current visualization field of view, or cropped and removed using a digital cropping function). The focal region may be automatically controlled by automatically detecting specific anatomical regions and suggesting these regions to the user to focus on them, either by semantic analysis of the imaging data or by using a single interaction, to automatically detect and focus on them without user input.

[0104] The console may include a computer program comprising algorithms for evaluating, calculating, and optimizing imaging parameters and for reconstructing images using heterogeneous spatial resolution and / or depth. As disclosed herein, imaging parameters may, in non-limiting embodiments, be plane-wave or divergent wavefront characteristics. Plane-wave or divergent wave characteristics may be at least one of the following: virtual source focus, distance, opening angle, steering angle, number of individual emission, transmission / reception pattern, transmission emission rate, imaging depth, rotation speed, rotation position, and three-dimensional (3D) wave direction steering. Imaging characteristics may, in non-limiting embodiments, be associated with at least one of the following: angular resolution, field of view, imaging depth, transmission / reception pattern, transmission emission rate, and plane-wave opening angle.

[0105] Using a defined algorithm, the console may be configured to provide feedback to the operator before or during the operation of the imaging array in order to evaluate, calculate, and optimize imaging parameters. Thus, the system provides visualization of information reconstructed assuming heterogeneous spatial resolution or depth.

[0106] In some embodiments of this system, the console actively communicates with a computing system that includes algorithms for evaluating, calculating, and selectively optimizing imaging parameters.

[0107] As described above, the transducer probe may be operably coupled to a console, which may generally control the operation of the transducer probe (i.e., the transmission of sound waves from the probe) and / or a controller. The console may generally include one or more processors (e.g., a central processing unit (CPU), a graphics processing unit (GPU), or both) and storage devices such as main memory, static memory, or a combination of both, which communicate with each other via a bus or equivalent. The memory according to embodiments of the present invention may include a machine-readable medium on which one or more sets of instructions (e.g., software) embodying one or more of the methodologies or functions described herein are stored. The software may also reside in main memory and / or a processor, all or at least partially, during its execution by the computer system, and the main memory and processor also constitute the machine-readable medium. The software may further be transmitted or received over a network, via a network interface device.

[0108] For example, in exemplary embodiments, the console may generally include a computing device configured to communicate across a network. The computing device may include one or more processors and memory, as well as input / output mechanisms (i.e., a keyboard, knobs, scroll wheel, or equivalent), which the operator can use to interact with the machine, including performing other tasks described herein, such as adjusting the transmission characteristics of the probe, saving images, and selecting specific areas of interest for subsequent reconstruction of heterogeneous data into 2D and / or 3D images.

[0109] During operation, the CPU and / or GPU may control the transmission and reception of current, subsequently resulting in the emission and reception of sound waves from the probe. The CPU and / or GPU may also analyze the electrical pulses generated by the probe in response to the reflected waves returning, and then convert this data into an image (i.e., an ultrasound image), which can then be viewed on a display, which may be an integrated monitor. Such an image may also be stored in memory and / or printed via a printer. The console may further provide control over the imaging assembly, including control over the emission of ultrasound pulses therefrom (intensity, frequency, duration, etc.) and control over the movement of the ultrasound transducer unit.

[0110] (Methods for selective image focusing) Figure 11 illustrates an embodiment of a method 1100 for selective imaging focus according to one embodiment of the present invention. The method includes: step 1101 providing a console configured to be operably associated with and exchange data with an ultrasonic imaging device; step 1103 defining a set of parameters via the console that are associated with the operation of an ultrasonic transducer unit of the ultrasonic imaging device to achieve imaging characteristics of one or more images captured via the ultrasonic imaging device with respect to a first selected region of interest; and step 1105 adjusting the set of parameters via the console, wherein the step of adjusting the set of parameters provides directional focusing and / or imaging quality control in a second selected region of interest such that characteristics and / or image quality are optimized with respect to one or more directions in the second selected region of interest compared to the first selected region of interest.

[0111] As described in detail herein, the console defines a set of parameters associated with the operation of the ultrasonic transducer unit of the ultrasonic imaging device in order to achieve imaging characteristics of one or more images captured via the ultrasonic imaging device with respect to a first selected region of interest. The console is configured to adjust the set of parameters. Adjusting the parameters provides directional focusing and / or imaging quality control in a second selected region of interest, such that imaging characteristics and / or image quality are optimized with respect to one or more directions in the second selected region of interest compared to the first selected region of interest.

[0112] Therefore, the set of parameters is defined with respect to the overall volume and may then be adjusted to optimize imaging in a selected region of interest or focal region within the volume. The method makes it possible to define multiple regions of interest by selectively fitting imaging parameters to achieve one or more desired imaging characteristics in the region of interest. The method may define a region of interest as an overall image, or define a region of interest or multiple regions of interest within a complete image, and selectively optimize imaging within the defined regions. This makes it possible to define multiple regions of interest, for example, one region being a complete image and one or more others being certain focal regions. Thus, the method of the present invention provides optimized imaging in the focal region compared to the overall volume, e.g., improved imaging contrast, resolution, sensitivity, and / or depth.

[0113] This method defines a set of parameters associated with the operation of the ultrasonic transducer unit of an ultrasonic imaging device in order to achieve imaging characteristics of one or more images captured via the ultrasonic imaging device. The imaging device may be, for example, a rotational transducer array or a 3D ultrasonic transducer. Thus, this concept may be applied to both 3D circumferential rotational imaging and 2D matrix array imaging systems, where penetration depth and (spatial) resolution can be specifically optimized to provide a focused view of a desired target region / anatomical structure, while full volumetric information is available to provide the user with an enhanced anatomical context.

[0114] In some embodiments of this method, the parameters include plane wave or divergent wavefront characteristics. For example, in non-limiting embodiments, the plane wave or divergent wave characteristics may be at least one of the following: virtual source focus, distance, opening angle, steering angle, number of individual flashes, transmission / reception pattern, transmission emission rate, imaging depth, rotation speed, rotation position, and three-dimensional (3D) wave direction steering.

[0115] Ultrafast ultrasound imaging techniques, such as plane wave or divergent wave imaging, may be required to enable imaging, particularly within the constraints of applications for intravascular and / or intracardiac tissue imaging. The method of the present invention enables the direct use of all inherent ultrafast imaging techniques. For example, in relation to intracardiac imaging, plane wave imaging may refer to an ultrasound imaging modality in which a plane wavefront can traverse tissue and be partially scattered back to the transducer through the flat transmission of all transducer elements (at different angles) from an angular imaging aperture. From the received radio frequency (RF) (i.e., channel) data, the overall image can be reconstructed simultaneously and in parallel by dynamically beamforming the RF data received for each target location.

[0116] As described, in the present invention, the transducer may be of any type for transmitting and receiving acoustic waves. For example, the transducer may include a one- or two-dimensional array of electronic transducer elements for transmitting and receiving acoustic waves. These arrays may include micro-electromechanical system (MEMS) based transducers such as capacitive micromachined ultrasonic transducers (CMUTs) and / or piezoelectric micromachined ultrasonic transducers (PMUTs).

[0117] CMUT devices offer superior bandwidth and acoustic impedance characteristics, making these transducers preferable to conventional piezoelectric transducers. Vibration of the CMUT film can be triggered by applying pressure (e.g., using ultrasound) or electrically induced. Often, electrical connections to the CMUT device, such as integrated circuits (ICs) like ASICs, facilitate both the transmission and reception modes of the device. In reception mode, changes in film position cause changes in electrical capacitance, which can be electronically detected during transmission mode; applying an electrical signal causes vibration of the film.

[0118] Piezoelectric micromachined ultrasonic transducers (PMUTs) are based on the flexural motion of a thin film coupled with a thin piezoelectric film such as PVDF. This is in contrast to bulk piezoelectric transducers, which use the thickness mode motion of a piezoelectric ceramic plate such as PZT or single-crystal PMN-PT. Compared to bulk piezoelectric ultrasonic transducers, PMUT devices offer advantages such as increased bandwidth, flexible geometry, natural acoustic impedance matched with water, reduced voltage requirements, and especially the mixing of different resonant frequencies and potentials for integration with supporting electronic circuits for miniaturization and high-frequency applications. Current PMUT devices do not require bias to achieve imaging sensitivity.

[0119] The transducer may be a micro-electromechanical system (MEMS) based capacitive micromachined ultrasonic transducer (CMUT) configured as a two-dimensional (2D) array structure. In non-limiting embodiments, the 2D array may be a flexible structure. The cylindrical imaging array may consist of a flexible 2D array structure in the CMUT design. Flexible MEMS-based arrays may be implemented by wafer thinning (CMUT / PMUT), as described, for example, in Mimoun, 2013, "A generic platform for the fabrication and assembly of flexible sensors for minimally invasive instruments," IEEE Sensors J 13(10) 3873-3882 (incorporated herein by reference), or by using specific approaches such as combining a rigid imaging cell with a flexible interconnect.

[0120] In addition, and / or alternatively, transducers may be fabricated from electrostrictive materials, configured as a two-dimensional (2D) array structure. Electrostriction is a property of all dielectric materials and consists of mechanical displacement as a response to an electronic field, such as material compression in a region of high electric field intensity. In electrostriction, the electric field applied to a material causes deformation of the material (direct effect), and the mechanical stress applied to the material changes the polarization of the material (inverse effect). Transducers may be fabricated from electrostrictive materials such as electrostrictive polymers, or any material that can be activated using a bias voltage to achieve imaging sensitivity.

[0121] The method of the present invention defines a set of parameters associated with the operation of an ultrasonic transducer unit of an ultrasonic imaging device. The parameters may be associated with plane wave or divergent wave characteristics. As described in detail herein, the plane wave or divergent wave characteristics may be, for example, virtual source focus, distance, opening angle, steering angle, number of individual flashes, transmission / reception pattern, transmission emission rate, imaging depth, rotation speed, rotation position, and three-dimensional (3D) wave direction steering.

[0122] In this context, a virtual source focus includes a method of coherently combining recorded data from multiple transmissions to form a composite focus that makes geometric assumptions about the transmissions. These also include divergent waves (virtual sources behind the array) and plane waves (virtual sources at infinity). Furthermore, the steering angle is not limited to a specific direction, but rather encompasses both lateral and elevation steering angles. To avoid bias due to the word "angle," steering angle is understood to mean steering in 3D.

[0123] It should be noted that the specific description of the present invention includes using the method of the present invention for ultrasound visualization of intravascular and / or intracardiac tissue, which may be particularly useful for catheter-based interventional procedures for assessing anatomical and functional data in relation to a target volume of interest. However, as is generally understood, the method of the present invention may be used for ultrasound visualization of any type of tissue in relation to any type of procedure in which imaging analysis is used and / or preferred.

[0124] In some embodiments of this method, the imaging characteristics are associated with at least one of the following: angular resolution, field of view, imaging depth, transmission / reception pattern, transmission emission rate, and plane wave opening angle.

[0125] For example, the method may first synchronize the current angular direction and then dynamically adapt other imaging parameters to achieve improved imaging. Based on the angular direction synchronization, the imaging parameters may be dynamically adapted during a single rotation / volume process so that the image quality and / or field of view are improved in a certain direction, and thus imaging achieves the desired optimization.

[0126] As disclosed herein, the console may be configured to dynamically define and / or adjust a set of parameters. Thus, the parameters may be adjusted during the image acquisition process, for example, during the process of one or more rotations.

[0127] As disclosed herein, selective image focusing may be achieved in several different ways. For example, firstly, by achieving synchronization between the emission and rotational position. Subsequently, selective improvement of image quality or field of view in a particular direction may be achieved by configuring a specific ultrasonic emission pattern. The phase between the motor position and the emission sequence may be modified to control the direction of the “focus region”. When a non-rotating ultrasonic design is used (e.g., in a 2D matrix array system or any other form of 3D ultrasonic system), emission and directional focusing / depth / resolution can be fully controlled through electronic element activation and delay (electron beamforming).

[0128] In some embodiments of this method, imaging characteristics are selected and adjusted by dynamically adapting the transmission / reception pattern in a first and / or second selected region of interest. For example, the transmission / reception emission rate may be adapted or modified to achieve higher angular resolution in a selected direction. Specifically, the emission rate may be increased within the selected region of interest during the rotation process to achieve higher angular resolution within the region of interest. Thus, the emission rate can be associated with the density of emission within a given region. Therefore, the emission rate may be higher in density compared to the density of emission in the rest of the rotation volume.

[0129] The imaging system is fundamentally limited by the ballistic time it takes for ultrasound to reach / reflect within the tissue, e.g., 1,540 m / sec for soft tissue. The system is limited to transmitting / receiving on only a portion of a full 2D array, or, if using a rotating array concept, the transmission / reception area is limited by the rotation of the array. Therefore, to maximize the emission density in one region, the overall volume imaging rate, i.e., the imaging rate over the entire rotation, may need to be reduced (e.g., imaging at 10 Hz only instead of 20 Hz), or the emission density or penetration depth may be reduced in a given region. Thus, this method allows for the selective modification of these parameters when applied to full-rotation imaging and selective optimization of imaging within the volume of the region of interest.

[0130] As disclosed herein, the method of the present invention provides continuous fitting of imaging parameters. For example, there may be one or more distinctly different imaging parameters or qualities defined by the system with respect to the inside and outside of the region of interest, but the system also enables continuous blending of parameters instead of discrete parameter sets for distinctly different regions. Thus, the method enables a change from discrete parameter definitions to continuous fitting of parameters in the region of interest, and provides continuous blending of imaging.

[0131] As discussed in detail above, the method may include an ultrasonic imaging device operably coupled to a console. The ultrasonic imaging device may include an ultrasonic transducer unit capable of 3D imaging. In some embodiments, the console further includes a controller for enabling the acquisition of plane wave or divergent wave acquired data over a 360-degree circumferential imaging area, where the first and / or second selected region of interest lies within the circumference encompassing the 360-degree imaging area.

[0132] As disclosed above, in some embodiments of the method, the controller can control a bias voltage selectively applied to one or more of a plurality of first and / or second electrodes of a transducer comprising an array of individual imaging elements. Thus, the bias voltage defines a voltage for a row or column connected to the electrodes, activating or deactivating imaging by individual imaging elements within the row or column, and defining the angular imaging aperture. The system may use matrix addressing in combination with bias activation to achieve an angular imaging aperture for ultrafast ultrasound imaging. Specifically, the system of the present invention may employ matrix addressing to adjust the imaging aperture.

[0133] Furthermore, the method of the present invention may also use a bias voltage to adjust the frequency range of the imaging array within the region of interest, and the sensitivity for the frequency range is driven by the bias voltage. The bias voltage may be used to completely deactivate imaging elements in the region of interest or within the volume as a whole. Importantly, using a bias voltage to activate imaging elements (i.e., cells) enables imaging without multiplexing. Bias activation means that when a nominal bias voltage is applied and the imaging array is adjusted to the target center frequency, imaging will be activated on the row or column in question. Similarly, applying a bias voltage of 0V or a voltage level at which the sensitivity of the imaging element is minimal will deactivate the imaging row or column. This allows for the activation or deactivation of entire rows or columns on the array and provides for employing a flexible transmission / reception scheme on rows and / or columns that are activated with respect to electron focusing.

[0134] In some embodiments of this method, the controller can control a rotary motor operably coupled to an ultrasonic transducer unit, enabling continuous rotation or positioning of the ultrasonic transducer unit.

[0135] In some embodiments of this method, the console may be configured to dynamically define and adjust a set of parameters during a single rotation process so that the imaging characteristics and / or image quality are optimized in a selected direction of a second selected area of ​​interest compared to the imaging characteristics and / or image quality within and outside a first selected area of ​​interest.

[0136] Furthermore, in some embodiments of this method, the console is configured to dynamically define and adjust a set of parameters so that the imaging characteristics and / or image quality are optimized over a continuous range of regions from a first selected region of interest to a second selected region of interest. The imaging characteristics and / or image quality may be optimized, for example, over the range of regions from the first selected region of interest to the second selected region of interest via linear interpolation of the set of parameters.

[0137] As described above, in some embodiments of the method, the console is further configured to synchronize the emission rate and emission direction of the ultrasonic transducer unit. The emission direction may be defined through the rotational position of the array, or, in the context of a 2D flat / flexible array, through the electronic control of individual transducer areas. The image characteristics within a second selected region of interest may be adjusted by dynamically adjusting the phase between at least the motor speed and emission rate of the ultrasonic transducer unit.

[0138] In some embodiments of this method, the set of parameters may be dynamically adjusted by optimizing the imaging depth and imaging resolution to provide a focused view of a first and / or second selected region of interest.

[0139] In some embodiments of this method, the imaging depth is adapted in the region of interest. Varying the imaging depth may allow for the creation of an asymmetric imaging volume around the circumference to selectively perform imaging of deeper structures in a certain direction. The imaging depth may be kept constant in other directions where imaging of deeper tissue is not important. This concept may also be applied to electron focusing / multiplexing and mechanical rotation. In some embodiments of the method of the present invention, the imaging resolution includes one or more of depth, lateral resolution, and angular resolution.

[0140] In some embodiments of the method of the present invention, the console is configured to adjust the imaging depth of the ultrasonic transducer unit, thereby creating an asymmetric imaging volume around the circumference and selectively performing imaging in a particular direction. As disclosed herein, the console may also be configured to adjust the emission rate of the ultrasonic transducer unit, thereby achieving higher angular resolution in a selected region of interest.

[0141] Furthermore, the console may be configured to adjust the plane-wave or divergent wavefront characteristics and steering angle of the ultrasonic transducer unit, thereby achieving complex shapes of the imaging volume in the selected region of interest.

[0142] In some embodiments of the method of the present invention, the plane wave opening and / or steering angle are adapted in the region of interest. Varying the plane wave opening and steering angles results in a complex shape of the imaging volume that can be adapted to image a certain volume of interest. For example, in one direction, the plane wave may extend at a wide angle to achieve a wide opening angle in that direction, while having a narrow-angle configuration in the other direction to achieve higher imaging quality in that direction. This can be useful in intracardiac imaging when the intracardiac imaging catheter is placed in the right atrium and selectively provides deeper imaging with higher resolution in the septal region. With respect to more lateral regions of the placement, such as the lungs, deeper penetration would not be required in terms of anatomical context.

[0143] In some embodiments of the method of the present invention, once good synchronization between emission and rotational position is achieved, selective image focusing can be achieved by configuring a specific ultrasonic emission pattern. The phase between the motor position and the emission sequence may be modified to control the direction of the “focus region”. When a non-rotating ultrasonic design is used (e.g., in a 2D matrix array system or any other form of 3D ultrasonic system), emission and directional focusing / depth / resolution can be fully controlled through electronic element activation and delay (electron beamforming).

[0144] Some embodiments of the method of the present invention provide mechanical solutions for non-uniform rotational speed and firing rate. For example, instead of varying the firing rate, the rotational speed may be varied by mechanical changes in the catheter, introducing friction inside the catheter in one direction. In some embodiments, the rotational speed of the ultrasonic transducer unit is varied by mechanical changes in the ultrasonic transducer unit.

[0145] For example, with respect to a rotating transducer with a constant rate of fire, using a mechanical change to slow down the transducer's rotation will result in more firing from the transducer element in the region where the rotation is slowed down. Using a constant rate of fire, this will result in more firing in that direction. For example, the mechanical change may be the area of ​​eccentricity in the rotating transducer. Eccentricity may be the result of adding rubber or other material to produce friction in the rotation of the transducer, for example.

[0146] In some embodiments, a mechanical change introduces friction inside the ultrasonic transducer unit in one direction, slowing down the rotation of the ultrasonic transducer unit. However, the system also allows for compensating for the mechanical behavior when friction is present inside the transducer unit so that it rotates more slowly in a certain region. Varying the firing rate in the region of interest or the volume as a whole compensates for this mechanical behavior. Therefore, in some embodiments of the method of the present invention, the firing rate is varied to compensate for the friction present inside the ultrasonic transducer unit. In some embodiments, the motor is non-discrete to change from one set of parameters to the next. In other embodiments of the system, the motor is a discrete function.

[0147] As described above, the selected region of focus may be based on a certain anatomical feature. In some embodiments, the first and / or second selected region of focus is defined based on one or more anatomical features. The anatomical feature may be, for example, a specific ablation pathway. Thus, the selected region of focus or focus region may be defined based on the anatomical structure being imaged.

[0148] The method of the present invention provides software-controlled fitting of imaging parameters, for example, through software-controlled focus area steering. In any of the modifications, the focus area may be freely selected and fitted in software by fitting the phase between the motor speed and the repeating firing pattern, or by fitting the transmission / reception pattern. The fitting may be performed dynamically during imaging.

[0149] The orientation of the focal region may be controlled in several ways. For example, the focal region may be presented directly to the user by setting the angle of the focal region, for example, through a user interface element, such as direct control of the focal region angle, or by directly indicating a specific area of ​​interest in the image using the mouse. The focal region may be implicitly controlled and / or adapted in combination with 3D visualization of the data. Thus, the focal region will be implicitly linked to an area within the central focus of the 3D visualization. If the viewpoint of the 3D visualization changes, the imaging focal region will be automatically adapted. This also takes into account knowledge of areas that are not displayed at all (outside the current visualization field of view, or cropped and removed using a digital cropping function). The focal region may be automatically controlled by automatically detecting specific anatomical regions and suggesting these regions to the user to focus on them, either by semantic analysis of the imaging data or by using a single interaction, to automatically detect and focus on them without user input.

[0150] The console may include a computer program comprising algorithms for evaluating, calculating, and optimizing imaging parameters and for reconstructing images using heterogeneous spatial resolution and / or depth. As disclosed herein, imaging parameters may, in non-limiting embodiments, be plane-wave or divergent wavefront characteristics. Plane-wave or divergent wave characteristics may be at least one of the following: virtual source focus, distance, opening angle, steering angle, number of individual emission, transmission / reception pattern, transmission emission rate, imaging depth, rotation speed, rotation position, and three-dimensional (3D) wave direction steering. Imaging characteristics may, in non-limiting embodiments, be associated with at least one of the following: angular resolution, field of view, imaging depth, transmission / reception pattern, transmission emission rate, and plane-wave opening angle.

[0151] Using a defined algorithm, the console may be configured to provide feedback to the operator before or during the operation of the imaging array in order to evaluate, calculate, and optimize imaging parameters. Thus, the system provides visualization of information reconstructed assuming heterogeneous spatial resolution or depth.

[0152] In some embodiments of this method, the console actively communicates with a computing system that includes algorithms for evaluating, calculating, and selectively optimizing imaging parameters.

[0153] As described above, the transducer probe may be operably coupled to a console, which may generally control the operation of the transducer probe (i.e., the transmission of sound waves from the probe) and / or a controller. The console may generally include one or more processors (e.g., a central processing unit (CPU), a graphics processing unit (GPU), or both) and storage devices such as main memory, static memory, or a combination of both, which communicate with each other via a bus or equivalent. The memory according to embodiments of the present invention may include a machine-readable medium on which one or more sets of instructions (e.g., software) embodying one or more of the methodologies or functions described herein are stored. The software may also reside in main memory and / or a processor, all or at least partially, during its execution by the computer system, and the main memory and processor also constitute the machine-readable medium. The software may further be transmitted or received over a network, via a network interface device.

[0154] For example, in exemplary embodiments, the console may generally include a computing device configured to communicate across a network. The computing device may include one or more processors and memory, as well as input / output mechanisms (i.e., a keyboard, knobs, scroll wheel, or equivalent), which the operator can use to interact with the machine, including performing other tasks described herein, such as adjusting the transmission characteristics of the probe, saving images, and selecting specific areas of interest for subsequent reconstruction of heterogeneous data into 2D and / or 3D images.

[0155] During operation, the CPU and / or GPU may control the transmission and reception of current, subsequently resulting in the emission and reception of sound waves from the probe. The CPU and / or GPU may also analyze the electrical pulses generated by the probe in response to the reflected waves returning, and then convert this data into an image (i.e., an ultrasound image), which can then be viewed on a display, which may be an integrated monitor. Such an image may also be stored in memory and / or printed via a printer. The console may further provide control over the imaging assembly, including control over the emission of ultrasound pulses therefrom (intensity, frequency, duration, etc.) and control over the movement of the ultrasound transducer unit.

[0156] As used in any embodiment of this specification, the term “module” may mean software, firmware, and / or a circuit configured to perform any of the operations described herein. Software may be embodied as software packages, code, instructions, instruction sets, and / or data recorded on a non-transient computer-readable storage medium. Firmware may be embodied as code, instructions, or instruction sets, and / or data hardcoded (e.g., non-volatile) within a memory device. “Circuitry” may, as used in any embodiment of this specification, include, for example, a wired network, a programmable network such as a computer processor comprising one or more individual instruction processing cores, a state-machine network, and / or firmware that stores instructions executed by a programmable network, either alone or in any combination. Modules may be embodied as a network that forms part of a larger system, collectively or individually, such as an integrated circuit (IC), a system-on-a-chip (SoC), a desktop computer, a laptop computer, a tablet computer, a server, a smartphone, and the like.

[0157] Any of the operations described herein may be implemented in a system including one or more storage media having instructions for performing the method, which are executed individually or in combination by one or more processors stored thereon. Here, the processors may include, for example, a server CPU, a mobile device CPU, and / or other programmable circuits.

[0158] Furthermore, it is intended that the operations described herein may be distributed across multiple physical devices, such as processing structures, in more than one different physical locations. The storage medium may include any type of tangible medium, such as any type of disk, including hard disks, floppy disks, optical disks, compact disk read-only memory (CD-ROM), rewritable compact disks (CD-RW), and magneto-optical disks; semiconductor devices such as read-only memory (ROM), random access memory (RAM) such as dynamic and static RAM, erasable programmable read-only memory (EPROM), electrically erasable programmable read-only memory (EEPROM), flash memory, solid-state disks (SSDs); magnetic or optical cards; or any type of medium suitable for storing electronic instructions. Other embodiments may be implemented as software modules executed by a programmable control device. The storage medium may be non-transient.

[0159] As described herein, various embodiments may be implemented using hardware elements, software elements, or any combination thereof. Examples of hardware elements may include processors, microprocessors, circuits, circuit elements (e.g., transistors, resistors, capacitors, inductors, etc.), integrated circuits, application-specific integrated circuits (ASICs), programmable logic devices (PLDs), digital signal processors (DSPs), field-programmable gate arrays (FPGAs), logic gates, registers, semiconductor devices, chips, microchips, chipsets, and the like.

[0160] Throughout this specification, any reference to “one embodiment” or “an embodiment” means that a particular feature, structure, or characteristic described in relation to an embodiment is included in at least one embodiment. Therefore, the expressions “in one embodiment” or “in an embodiment” in various places throughout this specification do not necessarily all refer to the same embodiment. Furthermore, certain features, structures, or characteristics may be combined in any preferred manner in one or more embodiments.

[0161] The term "non-transitory" is understood to exclude only the transient signals themselves from the scope of the claims, and not to waive rights to all standard computer-readable media other than the transient signals themselves. In other words, the terms "non-transitory computer-readable medium" and "non-transitory computer-readable storage medium" should be interpreted as excluding only those types of transient computer-readable media that were found to fall outside the scope of patentable subject matter under Section 101 of the U.S. Patent Act in the In Re Nuijten case.

[0162] The terms and expressions used herein are for illustrative purposes only, not limitation, and in using such terms and expressions, there is no intention to exclude any equivalents of the features (or parts thereof) shown and described, and it should be recognized that various modifications are possible within the scope of the claims. Therefore, the claims are intended to encompass all such equivalents.

[0163] (Integrated by reference) References and citations to other documents, such as patents, patent applications, patent publications, journals, books, articles, and web content, are made throughout this disclosure. All such documents are incorporated herein by reference to this specification for any purpose.

[0164] (Equal portions) Various modifications of the present invention and many further embodiments thereof will be apparent to those skilled in the art from the entirety of this document, including, in addition to those shown and described herein, references to scientific and patent documents cited herein. The subject matter of this specification contains important information, examples, and guidance that may be adapted to the practice of the invention in its various embodiments and equivalents thereof.

Claims

1. A system for providing selective image focusing, wherein the system is A hardware processor comprising a console configured to be operablely associated with and to exchange data with an ultrasonic imaging device, the console comprising a hardware processor coupled to a non-transient computer-readable memory containing instructions, The aforementioned command is sent to the console, To achieve imaging characteristics of one or more images captured via the ultrasonic imaging device relating to a first selected region of interest, define a set of parameters associated with the operation of the ultrasonic transducer unit of the ultrasonic imaging device. The method involves adjusting the set of parameters, wherein adjusting the set of parameters provides directional focusing and / or imaging quality control in the second selected region of interest, such that the imaging characteristics and / or image quality are optimized with respect to one or more directions in the second selected region of interest compared to the first selected region of interest. A system that is executable by the processor to perform the following actions.

2. The system according to claim 1, wherein the parameter has plane wave or divergent wavefront characteristics.

3. The system according to claim 2, wherein the plane wave or divergent wave characteristics include at least one of a virtual source focus, distance, opening angle, steering angle, number of individual emission cycles, transmission / reception pattern, transmission emission rate, imaging depth, rotation speed, rotation position, and three-dimensional (3D) wave direction steering.

4. The system according to claim 1, wherein the imaging characteristics are associated with at least one of angular resolution, field of view, imaging depth, transmission / reception pattern, transmission emission rate, and plane wave open angle.

5. The system according to claim 1, wherein the console is configured to dynamically define and / or adjust the set of parameters.

6. The system according to claim 5, wherein the imaging characteristics are selected and adjusted by dynamically adapting the transmission / reception pattern in the first and / or second selected region of interest.

7. The system according to claim 6, wherein the first and / or second selected region of interest is defined based on one or more anatomical features.

8. The system according to claim 5, wherein the set of parameters is dynamically adjusted by optimizing the imaging depth and imaging resolution to provide a focused view of the first and / or second selected region of interest.

9. The system according to claim 8, wherein the imaging resolution comprises one or more of depth resolution, lateral resolution, and angular resolution.

10. The system according to claim 2, further comprising an ultrasonic imaging device operably coupled to the console, wherein the ultrasonic imaging device comprises an ultrasonic transducer unit capable of 3D imaging around the entire circumference.

11. The system according to claim 10, wherein the console further comprises a controller for enabling the acquisition of plane wave or divergent wave acquisition data over a 360-degree circumferential imaging area, and the first and / or second selected area of ​​interest is located within the circumference encompassing the 360-degree imaging area.

12. The system according to claim 11, wherein the controller is capable of controlling a bias voltage selectively applied to one or more of a plurality of first and / or second electrodes of a transducer comprising an array of individual imaging elements, the bias voltage defines a voltage for a row or column connected to the electrodes, and activates or deactivates imaging by the individual imaging elements in the row or column and defines an angular imaging aperture.

13. The system according to claim 11, wherein the controller is capable of controlling a rotary motor operably coupled to the ultrasonic transducer unit, enabling continuous rotation or positioning of the ultrasonic transducer unit.

14. The system according to claim 10, wherein the console is configured to dynamically define and adjust the set of parameters during a single rotation process such that the imaging characteristics and / or image quality are optimized in a selected direction of the second selected area of ​​interest, compared to the imaging characteristics and / or image quality within and / or outside the first selected area of ​​interest.

15. The system according to claim 10, wherein the console is configured to dynamically define and adjust the set of parameters such that the imaging characteristics and / or image quality are optimized over a continuous range of regions from the first selected region of focus to the second selected region of focus.

16. The system according to claim 15, wherein the imaging characteristics and / or image quality are optimized by linear interpolation of the set of parameters over the range of the region from the first selected region of interest to the second selected region of interest.

17. The system according to claim 10, wherein the console is further configured to synchronize the emission rate and emission direction of the ultrasonic transducer unit, and the image characteristics in the second selected region of interest are adjusted by dynamically adjusting the phase between at least the motor speed and emission rate of the ultrasonic transducer unit.

18. The system according to claim 10, wherein the console is configured to adjust the imaging depth of the ultrasonic transducer unit, thereby creating an asymmetric imaging volume around the circumference and selectively performing imaging in a certain direction.

19. The system according to claim 10, wherein the console is configured to adjust the emission rate of the ultrasonic transducer unit to achieve a higher angular resolution in the selected area of ​​interest.

20. The system according to claim 10, wherein the console is configured to adjust the plane wave or divergent wavefront characteristics and steering angle of the ultrasonic transducer unit, thereby achieving a complex shape of the imaging volume in the selected region of interest.

21. The system according to claim 10, wherein the rotational speed of the ultrasonic transducer unit is varied by a mechanical change in the ultrasonic transducer unit.

22. The system according to claim 21, wherein the mechanical change introduces friction inside the ultrasonic transducer unit in one direction, thereby slowing down the rotation of the ultrasonic transducer unit.

23. The system according to claim 22, wherein the emission rate is varied to compensate for friction present inside the ultrasonic transducer unit.

24. A method for providing selective image focusing, wherein the method is To provide a console that is operablely associated with an ultrasound imaging device and configured to exchange data with it, To define a set of parameters associated with the operation of the ultrasonic transducer unit of the ultrasonic imaging device in order to achieve imaging characteristics of one or more images captured by the ultrasonic imaging device with respect to a first selected region of interest via the console, The adjustment of the set of parameters via the console provides directional focusing and / or imaging quality control in the second selected region of interest such that the characteristics and / or image quality are optimized with respect to one or more directions in the second selected region of interest compared to the first selected region of interest. Methods that include...

25. The method according to claim 24, wherein the parameter has plane wave or divergent wavefront characteristics.

26. The method according to claim 25, wherein the plane wave or divergent wave characteristics include at least one of a virtual source focus, distance, opening angle, steering angle, number of individual emission cycles, transmission / reception pattern, transmission emission rate, imaging depth, rotation speed, rotation position, and three-dimensional wave direction steering.

27. The method according to claim 24, wherein the imaging characteristics are associated with at least one of angular resolution, field of view, imaging depth, transmission / reception pattern, transmission emission rate, and plane wave open angle.

28. The method according to claim 24, wherein the console is configured to dynamically define and / or adjust the set of parameters.

29. The method according to claim 28, wherein the imaging characteristics are selected and adjusted by dynamically adapting the transmission / reception pattern in the first and / or second selected region of interest.

30. The method according to claim 29, wherein the first and / or second selected region of interest is defined based on one or more anatomical features.

31. The method according to claim 28, wherein the set of parameters is dynamically adjusted by optimizing the imaging depth and imaging resolution to provide a focused view of the region of interest.

32. The method according to claim 31, wherein the imaging resolution comprises one or more of depth resolution, lateral resolution, and angular resolution.

33. The method according to claim 24, further comprising providing an ultrasonic imaging device operably coupled to the console, wherein the ultrasonic imaging device comprises an ultrasonic transducer unit capable of 3D imaging around the entire circumference.

34. The method according to claim 33, wherein the console further comprises a controller for enabling the acquisition of plane wave or divergent wave acquisition data over a 360-degree circumferential imaging area, and the first and / or second selected area of ​​interest is located within the circumference encompassing the 360-degree imaging area.

35. The method according to claim 34, wherein the controller is capable of controlling a bias voltage selectively applied to one or more of a plurality of first and / or second electrodes of a transducer comprising an array of individual imaging elements, the bias voltage defines a voltage for a row or column connected to the electrodes, and activates or deactivates imaging by the individual imaging elements in the row or column and defines an angular imaging aperture.

36. The method according to claim 34, wherein the controller is capable of controlling a rotary motor operably coupled to the ultrasonic transducer unit, enabling continuous rotation or positioning of the ultrasonic transducer unit.

37. The method according to claim 33, wherein the console is configured to dynamically define and adjust the set of parameters during a single rotation process such that the imaging characteristics and / or image quality are improved in a selected direction of the second selected area of ​​interest compared to the imaging characteristics and / or image quality outside the first selected area of ​​interest.

38. The method according to claim 33, wherein the console is configured to dynamically define and adjust the set of parameters such that the imaging characteristics and / or image quality are optimized over a continuous range of regions from the first selected region of interest to the second selected region of interest.

39. The method according to claim 38, wherein the imaging characteristics and / or image quality are optimized by linear interpolation of the set of parameters over the range of the region from the first selected region of interest to the second selected region of interest.

40. The method according to claim 33, wherein the console is further configured to synchronize the emission rate and emission direction of the ultrasonic transducer unit, and the image characteristics in the second selected region of interest are adjusted by dynamically adjusting the phase between at least the motor speed and emission rate of the ultrasonic transducer unit.

41. The method according to claim 33, wherein the console is configured to adjust the imaging depth of the ultrasonic transducer unit, thereby creating an asymmetric imaging volume around the circumference and selectively performing imaging in a certain direction.

42. The method according to claim 33, wherein the console is configured to adjust the emission rate of the ultrasonic transducer unit to achieve a higher angular resolution in the second selected region of interest.

43. The method according to claim 33, wherein the console is configured to adjust the plane wave or divergent wavefront characteristics and steering angle of the ultrasonic transducer unit, thereby achieving a complex shape of the imaging volume in the region of interest.

44. The method according to claim 33, wherein the rotational speed of the ultrasonic transducer unit is varied by a mechanical change in the ultrasonic transducer unit.

45. The method according to claim 44, wherein the mechanical change introduces friction inside the ultrasonic transducer unit in one direction, thereby slowing down the rotation of the ultrasonic transducer unit.

46. The method according to claim 45, wherein the emission rate is varied to compensate for friction present inside the ultrasonic transducer unit.

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