Patent Description:
It may be easier to monitor the distance and orientation of the needle immediately after the percutaneous insertion when the needle plane is parallel to the image plane. While inadvertently moving or shifting the ultrasound probe, the clinician can lose the vein and/or the needle when adjusting the image plane before and after the percutaneous insertion which can result in a loss of valuable time. The existing ultrasound systems do not provide for convenient needle guidance capability that takes into account the inadvertent movement or shifting the ultrasound probe. Thus, what is needed are a method and system for an ultrasound image target tracking to account for the inadvertent movements or shifting of the ultrasound probe to facilitate efficient needle guidance.

Accordingly, disclosed herein are methods and systems for analyzing ultrasound images to detect targets including anatomic targets and medical devices appearing within an ultrasound imaging area and generating a cropped image to maintain a location of the detected targets in the cropped image in the event of a shift of the ultrasound probe head. <CIT> discloses a system comprising a survey imaging mode implemented to provide a volume image of a relatively large survey area. A target of interest is identified within the survey area for use in a target imaging mode. A target imaging mode is implemented to provide a volume image of a relatively small target area corresponding to the identified target of interest. The target imaging mode adapts the beamforming, volume field of view, and other signal and image processing algorithms to the target area. <CIT> discloses systems and methods for probe insertion using feedback from ultrasound guidance using anatomical features. There is disclosed ultrasound imaging for the generation of ultrasound images of anatomical features such as bone and/or visualizing ultrasound images of anatomical features in a subject being imaged. The disclosure includes real-time feedback using graphical user interface and ultrasonic imaging for the purpose of probe insertion. Probe insertion is idealistically displayed or physically guided.

Briefly summarized, disclosed herein is an ultrasound probe including, in some embodiments, an image target tracking capability. The ultrasound probe system may provide a consistent ultrasound view throughout an ultrasound guided procedure while compensating for inadvertent movements of the ultrasound probe. The exemplary tracking feature advantageously allows for incidental movement of the ultrasound probe during the procedure without drastic movement of the most important imaging data on the screen.

In some embodiments, an ultrasound imaging system is disclosed comprising an ultrasound probe including a transducer array configured to acquire ultrasound images, and a console including a processor and non-transitory computer-readable medium having stored thereon a plurality of logic modules that, when executed by the processor, are configured to perform operations including receiving an ultrasound image, detecting one or more targets within the ultrasound image, and generating a visualization from the ultrasound image to center the one or more detected targets within a displayed portion of the ultrasound image. In some embodiments, generating the visualization includes cropping the ultrasound image to center the one or more detected targets within a displayed portion of the ultrasound image. In some embodiments, generating the visualization includes increasing a magnification of a cropped portion of the ultrasound image to center the one or more detected targets within a displayed portion of the ultrasound image.

In some embodiments, the ultrasound probe is operatively connected to the console via a wired or wireless connection. In some embodiments, the console includes a display, and wherein the plurality of logic modules that, when executed by the processor, are configured to perform further operations including render the visualization of the cropped ultrasound image on a display. In some embodiments, detecting the one or more targets includes distinguishing a component within the ultrasound image according to varying color saturation within the ultrasound image. In specific embodiments, detecting the one or more targets includes identifying each of the one or more targets as a blood vessel, bone, organ or medical device. In other embodiments, identifying each of the one or more targets includes comparing characteristics of each of the one or more targets to thresholds set to define organs, blood vessels, bones or medical devices.

In some embodiments, the characteristics include one or more of a detected pulsatility upon analysis of the ultrasound image and a prior ultrasound image, dimensions of each of the one or more targets or color saturation of each of the one or more targets. In some embodiments, a result of comparing the characteristics to the one or more thresholds is a confidence level for each of the one or more targets indicating a likelihood of an identification of a particular target. In specific embodiments, the plurality of logic modules that, when executed by the processor, are configured to perform further operations including detect that at least a first target of the one or more of the targets is within a threshold distance of an edge of the ultrasound image.

In some embodiments, the plurality of logic modules that, when executed by the processor, are configured to perform further operations including generate an alert indicating to a clinician that the first target is within the threshold of the edge of the ultrasound image. In some embodiments, the alert includes a text notification or an arrow indicating a direction to move the ultrasound probe. In other embodiments, the one or more targets includes a blood vessel and a needle. In yet other embodiments, the one or more targets includes a distal tip of the needle.

In some embodiments, method for obtaining ultrasound images by an ultrasound imaging system is disclosed where the ultrasound imaging system includes an ultrasound probe including a transducer array configured to acquire ultrasound images, and a console including a processor and non-transitory computer-readable medium having stored thereon a plurality of logic modules that, when executed by the processor, are configured to perform operations including receiving an ultrasound image, detecting one or more targets within the ultrasound image, and generating a visualization from the ultrasound image by cropping the ultrasound image around the one or more detected targets. In some embodiments, the method comprises receiving an ultrasound image, detecting one or more targets within the ultrasound image, and generating a visualization from the ultrasound image to center the one or more detected targets within a displayed portion of the ultrasound image. In some embodiments, generating the visualization includes cropping the ultrasound image to center the one or more detected targets within a displayed portion of the ultrasound image. In some embodiments, generating the visualization includes increasing a magnification of a cropped portion of the ultrasound image to center the one or more detected targets within a displayed portion of the ultrasound image.

For clarity, it is to be understood that the word "distal" refers to a direction relatively closer to a patient on which a medical device is to be used as described herein, while the word "proximal" refers to a direction relatively further from the patient. Also, the words "including," "has," and "having," as used herein, including the claims, shall have the same meaning as the word "comprising.

Lastly, in the following description, the terms "or" and "and/or" as used herein are to be interpreted as inclusive or meaning any one or any combination. As an example, "A, B or C" or "A, B and/or C" mean "any of the following: A; B; C; A and B; A and C; B and C; A, B and C. " An exception to this definition will occur only when a combination of elements, components, functions, steps or acts are in some way inherently mutually exclusive.

Embodiments disclosed herein are directed to an ultrasound imaging system to be used for ultrasound imaging while placing a needle into a target vein of a patient. The ultrasound imaging system including, in some embodiments, an image target tracking capability is provided. The ultrasound imaging system may provide a consistent ultrasound view throughout an ultrasound guided procedure while compensating for inadvertent movements of an ultrasound probe. The exemplary tracking feature advantageously allows for incidental movement of the ultrasound probe during the procedure without drastic movement of the most important imaging data on the screen. The ultrasound-imaging system, according to the exemplary embodiments, may be primarily used for insertion of an access device such as a needle. The image tracking provides for the precise placement of the needle into a target vein or another anatomic target regardless of the inadvertent movements of the ultrasound probe.

Referring to <FIG>, a block diagram of the ultrasound imaging system <NUM> is shown in accordance with some embodiments is shown. The console <NUM> may house a variety of components of the ultrasound imaging system <NUM>. A processor <NUM> and memory <NUM> such as random-access memory (RAM) or non-volatile memory - e.g., electrically erasable programmable read-only memory EEPROM may be included in the console <NUM> for controlling functions of the ultrasound imaging system <NUM>, as well as for executing various logic operations or algorithms during operation of the ultrasound imaging system <NUM> in accordance with executable instructions <NUM> stored in the memory <NUM> for execution by the processor <NUM>. For example, the console <NUM> is configured to instantiate by way of the instructions <NUM> one or more processes for adjusting a distance of activated ultrasonic transducers <NUM> from a predefined target (e.g., a target vein) or an area, an orientation of the activated ultrasonic transducers <NUM> to the predefined target or area, or both the distance and the orientation of the activated ultrasonic transducers <NUM> with respect to the predefined target or area, as well as process electrical signals from the ultrasound probe <NUM> into ultrasound images. The activated ultrasonic transducers <NUM> may be adjusted using ultrasound-imaging data, magnetic-field data, fiber-optic shape-sensing data, or a combination thereof received by the console <NUM>. The console <NUM> may activate certain ultrasonic transducers of a <NUM>-D array of the ultrasonic transducers <NUM> or moving the already activated transducers in a linear array of the ultrasonic transducers <NUM>.

A digital controller/analog interface <NUM> may be also included with the console <NUM> and is in communication with both the processor <NUM> and other system components to govern interfacing between the ultrasound probe <NUM> and other system components set forth herein. The ultrasound imaging system <NUM> further includes ports <NUM> for connection with additional components such as optional components <NUM> including a printer, storage media, keyboard, etc. The ports <NUM> can be implemented as universal serial bus (USB) ports, though other types of ports can be used for this connection or any other connections shown or described herein. A power connection <NUM> is included with the console <NUM> to enable operable connection to an external power supply <NUM>. An internal power supply <NUM> (e.g., a battery) can also be employed either with or exclusive of the external power supply <NUM>. Power management circuitry <NUM> is included with the digital controller/analog interface <NUM> of the console <NUM> to regulate power use and distribution. Optionally, a stand-alone optical interrogator <NUM> may be communicatively coupled to the console <NUM> by way of one of the ports <NUM>. Alternatively, the console <NUM> may include an optical interrogator integrated into the console <NUM>. Such an optical interrogator is configured to emit input optical signals into a companion optical-fiber stylet <NUM> for shape sensing with the ultrasound imaging system <NUM>. The optical-fiber stylet <NUM>, in turn, may be configured to be inserted into a lumen of a medical device such as the needle and may convey the input optical signals from the optical interrogator <NUM> to a number of fiber Bragg grating (FBG) sensors along a length of the optical-fiber stylet <NUM>. The optical interrogator <NUM> may be also configured to receive reflected optical signals conveyed by the optical-fiber stylet <NUM> reflected from the number of the FBG sensors, the reflected optical signals may be indicative of a shape of the optical-fiber stylet <NUM>.

The optical interrogator <NUM> may be also configured to convert the reflected optical signals into corresponding electrical signals for processing by the console <NUM> into distance and orientation information with respect to the target and for dynamically adjusting a distance of the activated ultrasonic transducers <NUM>, an orientation of the activated ultrasonic transducers <NUM>, or both the distance and the orientation of the activated ultrasonic transducers <NUM> with respect to the target (e.g., a target vein) or the medical device (e.g., a needle) when it is brought into proximity of the target. For example, the distance and orientation of the activated ultrasonic transducers <NUM> may be adjusted with respect to the vein as the target. An image plane may be established by the activated ultrasonic transducers <NUM> being disposed at a particular angle to the target vein based on the orientation of the target vein (e.g., perpendicular or parallel among other configurations). In another example, when a medical device such as the needle is brought into proximity of the ultrasound probe <NUM>, an image plane can be established by the activated ultrasonic transducers <NUM> being perpendicular to a medical-device plane including the needle <NUM>. The distance and orientation information may also be used for displaying an iconographic representation of the medical device on the display.

The display screen <NUM> may be integrated into (or connected to) the console <NUM> to provide a GUI and display information for a clinician in a form of ultrasound images of the target acquired by the ultrasound probe <NUM>. In addition, the ultrasound imaging system <NUM> may enable the distance and orientation of a magnetized medical device such as the needle to be superimposed in real-time atop an ultrasound image of the target, thus enabling a clinician to accurately guide the magnetized medical device to the intended target (e.g., the vein). The display screen <NUM> can alternatively be separate from the console <NUM> and communicatively (e.g., wirelessly) coupled thereto. A console button interface <NUM> may be used to immediately call up a desired mode to the display screen <NUM> by the clinician for assistance in an ultrasound-based medical procedure. In some embodiments, the display screen <NUM> may be implemented as an LCD device. The ultrasound probe <NUM> may optionally include an internal measurement unit (IMU) <NUM> that may house and accelerometer <NUM>, a gyroscope <NUM> and a magnetometer <NUM>.

The ultrasound probe <NUM> may be employed in connection with ultrasound-based visualization of a target such as the vein in preparation for inserting the needle or another medical device into the target. Such visualization gives real-time ultrasound guidance and assists in reducing complications typically associated with such insertion, including inadvertent arterial puncture, hematoma, pneumothorax, etc. The ultrasound probe <NUM> may be configured to provide to the console <NUM> electrical signals corresponding to the ultrasound-imaging data, the magnetic-field data, the shape-sensing data, or a combination thereof for the real-time ultrasound needle guidance.

In one embodiment, target detection logic <NUM> may be executed by the processor <NUM> to detect vessels and other anatomic targets in the ultrasound images. The target detection logic <NUM> may include pulsatility detection logic <NUM> and component identification logic <NUM>. The target detection logic <NUM> may use pulsatility detection logic <NUM> and component identification logic <NUM>. The pulsatility detection logic <NUM> may compare a sequence of images of a vessel to detect pulses indicated by periodic changes in dimensions of the vessel (e.g., expansions in a diameter of the vessel). The target detection logic <NUM> may also detect bones by identifying tissues with high density based on color saturation in the ultrasound images. The component identification logic <NUM> may analyze reflection of echoes in each ultrasound image. This can be implemented, for example, using thresholds set to identify organs, blood vessels and bones. The respective logics <NUM>, <NUM> and <NUM> may be stored on a non-transitory computer-readable medium of the console <NUM>. An image cropping logic <NUM> may be executed on the processor <NUM> to crop images with the detected anatomic target (e.g., a target vein) so the anatomic target is in the center of the cropped image that of a total ultrasound imaging area as will be discussed in more detail herein. Herein, "cropping" may refer to reducing the amount of the ultrasound image that is displayed. Further, cropping may include increasing a magnification of the cropped portion of the ultrasound image. The target detection logic <NUM> and image cropping logic <NUM> may collectively be referred to as "console logic" or "logic of the console <NUM>"; however, the term console logic may also include reference to any of the other logic modules illustrated in <FIG>.

Referring to <FIG>, a probe connected to a console is shown in accordance with some embodiments is shown. In this example, the ultrasound probe <NUM> is connected to a console <NUM> over a wired connection. In one embodiment, a wireless connection may be used. The ultrasound probe <NUM> includes a body that may house a console operatively connected to an ultrasound imaging device <NUM>. The ultrasound probe <NUM> may be configured to assist a user such as a clinician in insertion of an access device such as a needle into a target vein <NUM> of a patient. Ultrasonic transducers located in a head <NUM> of the ultrasound probe are configured to capture <NUM>-D ultrasound images <NUM> to be displayed on a screen <NUM> of the console <NUM>. The head <NUM> may house a linear array of the ultrasonic transducers (not shown) or a <NUM>-D array of the ultrasonic transducers. The ultrasonic transducers may be implemented as piezoelectric transducers or capacitive micro-machined ultrasonic transducers (CMUTs). When the ultrasound probe <NUM> is configured with the <NUM>-D array of the ultrasonic transducers, a subset of the ultrasonic transducers may be linearly activated as needed for ultrasound imaging based on ultrasound-imaging data being captured.

The transducers may be configured to maintain the target in an image plane or switch to a different image plane (e.g., from a perpendicular plane to a medical-device plane to a plane parallel to the medical-device plane) including the target. If the ultrasound probe <NUM> is configured with the moveable linear array of the ultrasonic transducers, the ultrasonic transducers may be already activated for ultrasound imaging. For example, a subset of the ultrasonic transducers or all of the available ultrasonic transducers may be moved together on the moveable linear array as needed for ultrasound imaging based on the ultrasound-imaging data to maintain the target in an image plane established by the activated ultrasonic transducers or to switch to a different image plane including the target.

The probe head <NUM> may be placed against the skin of a patient proximate to a needle-insertion site so the activated ultrasonic transducers in the probe head <NUM> may generate and emit the generated ultrasound signals into the patient as a sequence of pulses. Then, the transmitters (not shown) may receive reflected ultrasound signals (i.e., reflections of the generated ultrasonic pulses from the patient's body). The reflected ultrasound signals may be converted into corresponding electrical signals for processing into ultrasound images by the console of the probe <NUM>. Thus, a clinician may employ the ultrasound imaging system <NUM> depicted in <FIG> to determine a suitable insertion site and establish vascular access to the target vein <NUM> with a needle or another medical device.

The ultrasound imaging system <NUM> depicted in <FIG> is capable of target vein <NUM> visualization in the total available ultrasound image <NUM> shown on a display <NUM> of a console <NUM>. In one embodiment, the image data is received from the probe <NUM> into the console <NUM> depicted in <FIG>. The target detection logic <NUM> may process the image data to render the ultrasound images in the total available ultrasound image <NUM>. As discussed above with reference to <FIG>, the target detection logic <NUM> may use pulsatility detection logic <NUM> and component identification logic <NUM>. The pulsatility detection logic <NUM> may compare a sequence of images of a vessel to detect pulses indicated by periodic changes in dimensions of the vessel (e.g., expansions in a diameter of the vessel). The component identification logic <NUM> may also detect bones by identifying tissues with high density based on color saturation in the ultrasound images. The component identification logic <NUM> may analyze reflection of echoes in each image. This can be implemented using thresholds set to define organs, blood vessels and bones. The respective logics may be stored on a non-transitory computer-readable medium of the console <NUM>. As discussed above, the target detection logic <NUM> may process the image data including the target vein <NUM> to render the ultrasound images <NUM>.

The ultrasound imaging system <NUM> depicted in <FIG> may be used for insertion procedure site assessment. Note that while the ultrasound probe assembly depicted in <FIG> has a generic shape, the ultrasound probe <NUM> may be of a different shape as long as the probe captures the insertion site and a target vein <NUM>.

Referring to now <FIG>, the probe <NUM> is shown as being connected to the console <NUM>, which is displaying a target vein <NUM> in a cropped image <NUM> of a total available ultrasound image. As discussed above with reference to <FIG>, the ultrasound probe <NUM> is connected to the console <NUM> over a wired connection. In one embodiment, a wireless connection may be used. The ultrasound probe <NUM> includes a body that may house a console operatively connected to an ultrasound imaging device <NUM>. The ultrasound probe <NUM> may be configured to assist a user such as a clinician in insertion of an access device such as a needle into a target vein <NUM> of a patient. The probe head <NUM> may be placed against the skin of a patient proximate to a needle-insertion site so the activated ultrasonic transducers in the probe head <NUM> may generate and emit ultrasound signals into the patient as a sequence of pulses. Then, the transmitters (not shown) may receive reflected ultrasound signals (i.e., reflections of the generated ultrasonic pulses from the patient's body). The reflected ultrasound signals may be converted into corresponding electrical signals for processing into ultrasound images by the console of the probe <NUM>. Thus, a clinician may employ the ultrasound imaging system <NUM> depicted in <FIG> to determine a suitable insertion site and establish vascular access to the target vein <NUM> with a needle or another medical device.

The ultrasound imaging system <NUM> depicted in <FIG> is capable of imaging and detecting a target vein <NUM> and providing visualizations as a cropped image <NUM> shown on the display <NUM> of the console <NUM>. The cropped image <NUM> is a subset of the total ultrasound image. In one embodiment, the image data is received from the probe <NUM> by the console <NUM> as depicted in <FIG>. The target detection logic <NUM> running on the console <NUM> may process the image data to detect an anatomic target (the target vein <NUM>) within the ultrasound images.

The target detection logic <NUM> may use pulsatility detection logic <NUM> and component identification logic <NUM> depicted in <FIG>. The pulsatility detection logic <NUM> may compare a sequence of images of a vessel to detect pulses indicated by periodic changes in dimensions of the vessel (e.g., expansions in a diameter of the vessel). The component identification logic <NUM> may also detect bones by identifying tissues with high density based on color saturation in the ultrasound images. The component identification logic <NUM> may analyze reflection of echoes in each ultrasound image. This can be implemented using thresholds set to define anatomic targets such as organs, blood vessels, bones, etc. In one embodiment, the image cropping logic <NUM> depicted in <FIG> may crop the ultrasound image capturing the imaging area <NUM> such that the detected anatomic target (e.g., the target vein <NUM>) is located the center of the cropped image <NUM>. Then, the cropped image <NUM> includes the vein <NUM> at its center and is displayed in the display <NUM> of the console <NUM>. In addition to cropping the ultrasound image capturing the imaging area <NUM>, the cropped image <NUM> may be magnified to fill, or substantially fill, the display <NUM>. As seen in a comparison of <FIG>, the image of the target vein <NUM> in <FIG> appears larger than the image of the target vein <NUM> in <FIG>, which indicates a magnification has occurred with the cropped image <NUM>.

Referring now to <FIG>, a view of a display of a cropped image of a target vein is shown in accordance with some embodiments. As discussed with reference to <FIG>, the ultrasound probe <NUM> includes a body and a head <NUM> that houses transducers that may generate and emit the generated ultrasound signals into the patient. The ultrasound imaging system <NUM> depicted in <FIG> is configured to obtain ultrasound images, detect the target vein <NUM> and render a cropped visualization on a display illustrating of the target vein <NUM>. In this example, the ultrasound probe <NUM> emits ultrasound pulses causing the ultrasound probe <NUM> to receive reflected data encompassing an imaging area <NUM>, which includes the target vein <NUM>.

The ultrasound image of the imaging area <NUM> is provided to the console <NUM> where the console logic processes the ultrasound image. Specifically, the target detection logic <NUM> analyzes the ultrasound image to detect the target vein <NUM>. For example, the target detection logic <NUM> may place a bounding box surrounding the target vein <NUM> or may detect coordinates of a box around the target vein <NUM>. It should be understood that the term "box" is not limited to a square or rectangle but may refer to any other shape, such as a circle, oval, etc. The image cropping logic <NUM> then crops the ultrasound image illustrating imaging area <NUM> around the image of the target vein <NUM> in such a way that the target vein <NUM> is located in the center of the cropped image <NUM>. For example, the image cropping logic <NUM>, when executed by the processor <NUM>, may crop the ultrasound image illustrating the imaging area <NUM> at the bounding box or coordinates determined by the target detection logic <NUM>. Then, the cropped image <NUM> containing the target vein <NUM> may be displayed on the screen of the console <NUM>.

Referring to <FIG>, a view of visualization of a cropped image of a target vein when the probe shifts is shown in accordance with some embodiments. In this example, the probe <NUM> inadvertently shifts in a first direction, e.g., to the left. The shift of the probe <NUM> may produce a corresponding shift of the location of the target vein <NUM> within the imaging area <NUM>, where the corresponding shift of the target vein <NUM> may be thought of as being in a second direction opposite the first direction.

However, according to an exemplary embodiment, logic of the ultrasound imaging system <NUM> is configured to detect the target vein <NUM> and display an image on the console <NUM> where the target vein <NUM> is displayed in the center of the image (i.e., compensating for the shift of the probe <NUM>). Therefore, even as the probe <NUM> may be inadvertently shifted, the image displayed by the console <NUM> does maintains the target vein <NUM> at the center of the displayed image; thus, enabling the clinician to continue focusing on the target vein <NUM> itself as opposed to focusing on the inadvertent shift of the probe <NUM>.

In other words, the cropped image <NUM> advantageously does not change in response to the shifting of the probe <NUM>. The ultrasound imaging system <NUM> may identify and distinguish anatomic targets such as the target vein <NUM>. Then, the ultrasound imaging system <NUM> may identify the anatomic target and perform image tracking of that target. The console <NUM> of the ultrasound imaging system <NUM> may employ console logic (e.g., target detection logic <NUM> and image cropping logic <NUM>, as referenced above) to receive a sequence of ultrasound images (or a continuous signal) from the probe <NUM>. Further, the console logic may repeatedly detect the target vein <NUM> within each image and may crop the current image for visualization (e.g., as the cropped image <NUM>). This way, the display of the cropped image <NUM> of the target vein <NUM> remains unaffected by the shifting of the probe <NUM> allowing the clinician to advantageously maintain sight of the visualization of the target vein <NUM>.

Referring now to <FIG>, a view of a display of a cropped image of a target vein with a movement warning when the probe shifts is shown in accordance with some embodiments. In one embodiment, the ultrasound imaging system <NUM> may retain and communicate information on the location of the identified target vein <NUM>. For example, the console logic may determine that a shift of the probe <NUM> has resulted in the target vein <NUM> being within a threshold distance from an edge of the imaging area <NUM> and in response, generate a warning or indication (e.g., such as the warning <NUM>) that is configured to inform the user (e.g., a clinician) that the target vein <NUM> may soon be out of sight of the probe <NUM> due to shifts or movement of the probe <NUM>. In some embodiments, the warning or indication may be a visual warning displayed by the console <NUM> such as the warning <NUM> as seen in <FIG>. The warning <NUM> may include text, e.g., "Movement warning" and/or an indication of a direction in which to move the probe <NUM> relative to the target vein <NUM> (e.g., the arrow <NUM>) in order to more centrally locate the ultrasound imaging area <NUM> over the target vein <NUM>.

For example, the console logic may detect the target vein <NUM> in each ultrasound image received from the probe <NUM>. When the ultrasound probe <NUM> accidentally moves in such a way that the probe head <NUM> is about to stop capturing the target vein <NUM>, the console logic provides a "movement warning" alert that is displayed on the display <NUM>, e.g., as an overlay on the cropped image <NUM>. The console logic may detect the location of the target vein <NUM> relative to boundaries of the total ultrasound image area <NUM>. The visual alert may be accompanied by an arrow indicating which way to move the probe to get away from the edge of the screen. This way, the clinician is alerted in time before losing sight of the visualization of the target vein <NUM>. In one embodiment, the "movement warning" alert may be generated by an alert generating logic component of the console logic. In some embodiments, the warning or alert may be an audio alert such as beeping. In some embodiments, the warning or alert may be a vibration of the probe <NUM>, in which case the probe <NUM> would include a vibration motor that is communicatively coupled to the console logic. In some embodiments, the warning or alert may be any combination of a visual alert, an audio alert and/or a vibration.

Referring now to <FIG>, a view of a warning message displayed on a console display when the probe shifts and no longer captures the target vein is shown in accordance with some embodiments. As discussed above, the ultrasound imaging system <NUM> may retain and communicate information on the location of the identified target vein <NUM>. For example, the console logic may inform the clinician that the target vein <NUM> has moved off the screen in a specific direction, e.g., by analyzing an ultrasound image, failing to detect the target vein <NUM>, and generating a visualization to be rendered on the display <NUM>. When the ultrasound probe <NUM> moves in such a way (shown by double arrows) that it is no longer capturing the target vein <NUM> (i.e., the target vein is not within the imaging area <NUM>), the console logic can generate an alert configured to be rendered on the display <NUM> for viewing by the clinician.

In the example depicted in <FIG>, console logic may analyze each ultrasound image received from the probe <NUM> in order to detect the target vein <NUM>. When the ultrasound probe <NUM> accidentally moves in such a way that the probe head <NUM> is no longer capturing the target vein <NUM> (e.g., the target vein <NUM> is outside of the imaging area <NUM>), the console logic provides a "movement warning" alert that is displayed on the display <NUM>, e.g., as an overlay on the cropped image <NUM>. For instance, the console logic may provide a "Move Probe" message alert <NUM> that is displayed as an overlay over a rendering of the total imaging area <NUM>. In some embodiments, the console logic may also provide an arrow <NUM> that indicates the direction in which the probe needs to be moved in order to resume capturing of the target vein <NUM>. This way, the clinician is alerted to move the probe and resume the visualization of the target vein <NUM>.

Referring to <FIG>, the probe connected to the console of <FIG> including imaging of a target vein and a needle is shown in accordance with some embodiments is shown. As noted above, the ultrasound probe <NUM> may be connected to the console <NUM> via a wired or wireless connection. As illustrated, the probe head <NUM> may be placed against the skin of a patient proximate to a needle-insertion site so the activated ultrasonic transducers in the probe head <NUM> may generate and emit the generated ultrasound signals into the patient as a sequence of pulses. Then, the transmitters (not shown) may receive reflected ultrasound signals (i.e., reflections of the generated ultrasonic pulses from the patient's body). The reflected ultrasound signals may be converted into corresponding electrical signals for processing into ultrasound images by the console of the probe <NUM>. Thus, a clinician may employ the ultrasound imaging system <NUM> depicted in <FIG> to determine a suitable insertion site and establish vascular access to the target vein <NUM> with a needle or another medical device. Further, the reflected ultrasound signals may include reflections from the needle <NUM>, thus enabling the ultrasound imaging system <NUM> to display an ultrasound image illustrating the imaging area <NUM>.

Referring to now <FIG>, the probe <NUM> is shown as being connected to the console <NUM>, which is displaying a target vein <NUM> and a portion of the needle <NUM> in a cropped image <NUM> of a total available ultrasound image. As discussed, the ultrasound imaging system <NUM> may be configured to obtain an ultrasound image illustrating an ultrasound imaging area <NUM> and render a cropped image <NUM> illustrating a portion of the ultrasound imaging area <NUM> on the display <NUM> of the console <NUM>. In some such embodiments, target detection logic <NUM> of the console <NUM> may process the image data (ultrasound reflection data) to crop the ultrasound images and cause the rendering of the cropped image <NUM>. Specifically, the target detection logic <NUM> may use pulsatility detection logic <NUM> and component identification logic <NUM>. The pulsatility detection logic <NUM> may compare a sequence of images of a vessel to detect pulses indicated by periodic changes in dimensions of the vessel (e.g., expansions in a diameter of the vessel). The component identification logic <NUM> may also detect bones by identifying tissues with high density based on color saturation in the ultrasound images.

The component identification logic <NUM> may analyze reflection of echoes in each image. The identification of components may be implemented based on comparing characteristics of detected components (e.g., pulsatility over a plurality of images, dimensions of the detected components, color saturation, etc.) to thresholds set to define organs, blood vessels and bones. Based on the result of comparing the characteristics of detected components to the one or more thresholds, a confidence level (or score) may be determined indicating a likelihood of an identification of a particular component (e.g., a confidence score that a particular detected component is a bone or a blood vessel).

Further and in a similar manner, the target detection logic <NUM> may also be configured to detect a needle with an ultrasound image. A needle, such as the needle <NUM>, may include specific and known reflection characteristics (e.g., dimensions, color saturation, etc.) such that the component identification logic <NUM> of the target detection logic <NUM> may detect and identify a needle in the same manner as discussed with respect to vessel and bone detection. Thus, the ultrasound probe <NUM> may be configured to assist a user such as a clinician in insertion of an access device, e.g., the needle <NUM>, into a target vein <NUM> of a patient. The probe head <NUM> may be placed against the skin of a patient proximate to a needle-insertion site so the activated ultrasonic transducers in the probe head <NUM> may generate and emit ultrasound signals into the patient as a sequence of pulses. Then, the transmitters (not shown) may receive reflected ultrasound signals (i.e., reflections of the generated ultrasonic pulses from the patient's body). The reflected ultrasound signals may be converted into corresponding electrical signals for processing into ultrasound images by the console of the probe <NUM>. Thus, a clinician may employ the ultrasound imaging system <NUM> depicted in <FIG> to determine a suitable insertion site and establish vascular access to the target vein <NUM> with a needle or another medical device.

Following detection and identification of components included within the imaging area <NUM>, the ultrasound imaging system <NUM> may be configured to generate a cropped image, such as the cropped image <NUM>, which includes both the target vein <NUM> and a portion of the needle <NUM>. In one embodiment, the image cropping logic <NUM> depicted in <FIG> may crop the ultrasound image illustrating the imaging area <NUM> such that the detected anatomic target (e.g., the target vein <NUM>) is located the center of the cropped image <NUM>. Then, the cropped image <NUM> includes the vein <NUM> at its center and is displayed on the display <NUM> of the console <NUM>. In addition to cropping the ultrasound image <NUM>, the cropped image <NUM> may be magnified to fill, or substantially fill, the display <NUM>. As seen in a comparison of <FIG>, the image of the target vein <NUM> in <FIG> appears larger than the image of the target vein <NUM> in <FIG>, which indicates a magnification has occurred with the cropped image <NUM>.

In some embodiments, a determination of a boundary at which to crop the ultrasound image illustrating the imaging area <NUM> includes determination of the positioning of the needle <NUM> and its distance from the target vein <NUM>. For example, the cropped image <NUM> may consist of a smaller bounding box surrounding the target vein <NUM> when the needle <NUM> is in close proximity to the target vein <NUM> and consist of a larger bounding box when the needle <NUM> is further away from the target vein <NUM>. Therefore, in both situations, the cropped image <NUM> illustrates the target vein <NUM> and the needle <NUM>. However, in other embodiments, the bounding box upon which the cropped image <NUM> is created is a predetermined size and cropping would not take into consideration a location of the needle <NUM>. As noted above, it should be understood that the term "box" is not limited to a square or rectangle but may refer to any other shape, such as a circle, oval, etc..

Referring now to <FIG>, a view of a display of a cropped image of a target vein and a portion of a needle is shown in accordance with some embodiments. As discussed with reference to <FIG>, the ultrasound imaging system <NUM> is configured to obtain ultrasound images, detect the target vein <NUM> and the needle <NUM>, including the distal tip <NUM> of the needle <NUM>. Additionally, the ultrasound imaging system <NUM> may be configured to render a cropped visualization, e.g., the cropped image <NUM>, on a display illustrating of the target vein <NUM> and the needle <NUM>. In some embodiments, the needle tip tracking can be implemented using the teachings of one or more patents of <CIT>; <CIT>; <CIT>;<CIT>; and<CIT>.

Referring to <FIG>, a view of visualization of a cropped image of a target vein and a portion of a needle is shown in accordance with some embodiments. In this example, the probe <NUM> inadvertently shifts in a first direction, e.g., to the left. The shift of the probe <NUM> may produce a corresponding shift of the location of the target vein <NUM> within the imaging area <NUM>, where the corresponding shift of the target vein <NUM> may be thought of as being in a second direction opposite the first direction. However, according to the exemplary embodiment, there is no change occurs in the cropped image <NUM> of the vein <NUM> and the distal tip <NUM> shown to a clinician in the cropped image <NUM> following the accidental shifting of the probe <NUM>. In other words, the cropped image <NUM> advantageously does not change in response to the shifting of the probe <NUM>. The ultrasound imaging system <NUM> may identify and distinguish anatomic targets such as the target vein <NUM> and the distal tip <NUM> of the needle <NUM> in order to perform image tracking of the distal tip <NUM>. The ultrasound imaging system <NUM> may employ console logic to receive a sequence of ultrasound images (or a continuous signal) from the probe <NUM>. Then, the console logic may repeatedly detect the target vein <NUM> within each image and may crop the current image for visualization in the cropped image <NUM>. This way the target vein <NUM> displayed in the cropped image <NUM> remains unaffected by the shifting of the probe <NUM>. In other words, focus is maintained on the target vein <NUM> and on the tracking of the needle tip <NUM>. Thus, the clinician advantageously does not lose sight of the visualization of the target vein <NUM> and tracking of the distal tip <NUM>.

In other words, the cropped image <NUM> advantageously does not change in response to the shifting of the probe <NUM>. The ultrasound imaging system <NUM> may identify and distinguish anatomic targets such as the target vein <NUM>. Then, the ultrasound imaging system <NUM> may identify the anatomic target and perform image tracking of that target. The console <NUM> of the ultrasound imaging system <NUM> may employ console logic (e.g., target detection logic <NUM> and image cropping logic <NUM>, as referenced above) to receive a sequence of ultrasound images (or a continuous signal) from the probe <NUM>. Further, the console logic may repeatedly detect the target vein <NUM> and the needle <NUM> within each image and may crop the current image for visualization (e.g., as the cropped image <NUM>). This way, the display of the cropped image <NUM> of the target vein <NUM> remains unaffected by the shifting of the probe <NUM> allowing the clinician to advantageously maintain sight of the visualization of the target vein <NUM> and the needle <NUM> as the needle <NUM> approaches the target vein <NUM>.

Referring now to <FIG>, a view of a display of a cropped image of a target vein and a portion of a needle including a movement warning when the probe shifts is shown in accordance with some embodiments. In one embodiment, the ultrasound imaging system <NUM> may retain and communicate information on the location of the identified target vein <NUM>. For example, the console logic may determine that a shift of the probe <NUM> has resulted in the target vein <NUM> and/or a distal tip <NUM> of the needle <NUM> being within a threshold distance from an edge of the imaging area <NUM> and in response, generate a warning or indication (e.g., such as the warning <NUM>) that is configured to inform the user (e.g., a clinician) that the target vein <NUM> or the distal tip <NUM> of the needle <NUM> may soon be out of sight of the probe <NUM> due to shifts or movement of the probe <NUM>. In some embodiments, the warning or indication may be a visual warning displayed by the console <NUM> such as the warning <NUM> as seen in <FIG>. The warning <NUM> may include text, e.g., "Movement warning" and/or an indication of a direction in which to move the probe <NUM> relative to the target vein <NUM> (e.g., the arrow <NUM>) in order to more centrally locate the ultrasound imaging area <NUM> over the target vein <NUM>.

For example, the console logic may detect the target vein <NUM> and the needle <NUM>, include a distal tip <NUM> of the needle <NUM>, in each ultrasound image received from the probe <NUM>. When the ultrasound probe <NUM> accidentally moves in such a way that the probe head <NUM> is about to stop capturing the target vein <NUM> or the distal tip <NUM> of the needle <NUM>, the console logic provides a "movement warning" alert that is displayed on the display <NUM>, e.g., as an overlay on the cropped image <NUM>. The console logic may detect the location of the target vein <NUM> relative to boundaries of the total ultrasound image area <NUM>. The visual alert may be accompanied by an arrow indicating which way to move the probe to get away from the edge of the screen. This way, the clinician is alerted in time before losing sight of the visualization of the target vein <NUM> or the distal tip <NUM> of the needle <NUM>. In one embodiment, the "movement warning" alert may be generated by an alert generating logic component of the console logic. In some embodiments, the warning or alert may be an audio alert such as beeping. In some embodiments, the warning or alert may be a vibration of the probe <NUM>, in which case the probe <NUM> would include a vibration motor that is communicatively coupled to the console logic. In some embodiments, the warning or alert may be any combination of a visual alert, an audio alert and/or a vibration.

Having a system that not only provides for ultrasound imaging, but ensures that the needle is precisely inserted into a target based on ultrasound image tracking regardless of accidental shifting the ultrasound probe, advantageously reduces a risk of puncturing patient's skin in a wrong place or even in several places.

Claim 1:
An ultrasound imaging system (<NUM>) comprising:
an ultrasound probe (<NUM>, <NUM>) including a transducer array (<NUM>) configured to acquire ultrasound images; and
a console (<NUM>) including a processor (<NUM>) and non-transitory computer-readable medium having stored thereon a plurality of logic modules that, when executed by the processor (<NUM>), are configured to perform operations including:
receiving an ultrasound image (<NUM>),
detecting one or more targets within the ultrasound image (<NUM>), and
generating a visualization from the ultrasound image (<NUM>) to center the one or more detected targets within a displayed portion of the ultrasound image (<NUM>).