High Fidelity Doppler Ultrasound Using Vessel Detection For Relative Orientation

Dynamically adjusting ultrasound-imaging systems include an ultrasound probe, a console, and a display screen. The ultrasound probe includes an array of ultrasonic transducers that, when activated, emit generated ultrasound signals into a patient, receive reflected ultrasound signals from the patient, and convert the reflected ultrasound signals into corresponding electrical signals for processing into ultrasound images. The console is configured to execute instructions for defining an orientation of an image plane with respect to a blood vessel based on a shape a blood image and further with respect to a direction of blood flow within the blood vessel via doppler ultrasound. The orientation of image plane may be defined by a comparison of an ultrasound image with corresponding ultrasound images stored in memory. The system may automatically reorient the image plane to align with the blood vessel.

BACKGROUND

Ultrasound imaging is a widely accepted tool for guiding interventional instruments such as needles to targets such as blood vessels or organs in the human body. In order to successfully guide, for example, a needle to a blood vessel using ultrasound imaging, the needle is monitored in real-time both immediately before and after a percutaneous puncture in order to enable a clinician to determine the distance and the orientation of the needle to the blood vessel and ensure successful access thereto. However, through inadvertent movement of an ultrasound probe during the ultrasound imaging, the clinician can lose both the blood vessel and the needle, which can be difficult and time consuming to find again. In addition, it is often easier to monitor the distance and orientation of the needle immediately before the percutaneous puncture with a needle plane including the needle perpendicular to an image plane of the ultrasound probe. And it is often easier to monitor the distance and orientation of the needle immediately after the percutaneous puncture with the needle plane parallel to the image plane. As with inadvertently moving the ultrasound probe, the clinician can lose both the blood vessel and the needle when adjusting the image plane before and after the percutaneous puncture, which can be difficult and time consuming to find again. What is needed are ultrasound-imaging systems and methods thereof that can dynamically adjust the image plane to facilitate guiding interventional instruments to targets in at least the human body.

Doppler ultrasound is a noninvasive approach to estimating the blood flow through your blood vessels by bouncing high-frequency sound waves (ultrasound) off circulating red blood cells. A doppler ultrasound can estimate how fast blood flows by measuring the rate of change in its pitch (frequency). Doppler ultrasound may be performed as an alternative to more-invasive procedures, such as angiography, which involves injecting dye into the blood vessels so that they show up clearly on X-ray images. Doppler ultrasound may help diagnose many conditions, including blood clots, poorly functioning valves in your leg veins, which can cause blood or other fluids to pool in your legs (venous insufficiency), heart valve defects and congenital heart disease, a blocked artery (arterial occlusion), decreased blood circulation into your legs (peripheral artery disease), bulging arteries (aneurysms), and narrowing of an artery, such as in your neck (carotid artery stenosis). Doppler ultrasound may also detect a direction of blood flow within a blood vessel.

Disclosed herein are systems and methods for combining ultrasound imaging with doppler ultrasound to establish an orientation of the ultrasound image plane with respect to a blood vessel within the ultrasound image.

SUMMARY

Disclosed herein is an ultrasound-imaging system including, in some embodiments, an ultrasound probe having an array of ultrasonic transducers, where activated ultrasonic transducers of the array of ultrasonic transducers are configured to emit generated ultrasound signals into a patient, receive reflected ultrasound signals from the patient, and convert the reflected ultrasound signals into corresponding electrical signals of the ultrasound signals for processing into ultrasound images. The system further includes a console configured to communicate with the ultrasound probe, where the console includes one or more processors and a non-transitory computer-readable medium having stored thereon logic, that when executed by the one or more processors, causes system operations. The operations include: (i) defining an ultrasound image of a blood vessel in accordance with an image plane of the ultrasound probe, (ii) determining a misalignment between the blood vessel and the image plane, (iii) providing notification in response to determining the misalignment, and (iv) causing a rendering of the ultrasound image of a blood vessel on a display of the system. In some embodiments, the notification is tactile, audible, visual, or any combination thereof. In still further embodiments, the operations further include adjusting an orientation of the activated ultrasonic transducers to orient the image plane perpendicular to the blood vessel.

In some embodiments, the ultrasound image of a blood vessel defines an elliptical shape and in further embodiments, determining the misalignment includes: (i) identifying a length and a width of the elliptical shape, (ii) calculating a parameter relating to a difference between the length and the width, and (iii) comparing the calculated parameter with a parameter limit stored in memory.

In some embodiments, the ultrasound probe includes doppler ultrasound capability, and the operations further include determining a direction of blood flow within the blood vessel with respect the image plane based on doppler ultrasound data. In further embodiments, rendering the ultrasound image of the blood vessel includes superimposing an indicum atop the ultrasound image of the blood vessel, where the indicum indicates the direction of the blood flow.

The operations may further include: (i) comparing the ultrasound image of the blood vessel with one or more ultrasound images of blood vessels stored in memory, where the one or more ultrasound images pertain to a defined medical procedure, and (ii) providing a notification when, as a result of the comparison, an orientation of the image plane of the ultrasound image of the blood vessel is determined to be opposite to an orientation of a corresponding image plane of the one or more ultrasound images. In some embodiments, comparing the ultrasound image includes comparing the spatial positioning of the blood vessel in relation to adjacent anatomical elements in the ultrasound image of the blood vessel with the spatial positioning of a corresponding blood vessel in relation to corresponding adjacent anatomical elements in the one or more ultrasound images.

The ultrasound probe may, in some embodiments, further include an array of magnetic sensors configured to convert magnetic signals from a magnetized medical device into corresponding electrical signals of the magnetic signals for processing by the processor into distance and orientation information with respect to the blood vessel for display of an iconographic representation of the medical device on the display screen. In some embodiments, the distance and orientation of the activated ultrasonic transducers is adjusted with respect to the blood vessel so that when the medical device is brought into proximity of the ultrasound probe, a device image plane is established by the activated ultrasonic transducers that is perpendicular or parallel to a medical-device plane including the medical device for accessing the blood vessel with the medical device.

The system may further include: (1) a stand-alone optical interrogator communicatively coupled to the console or an integrated optical interrogator integrated into the console, where the optical interrogator is configured to (i) emit input optical signals, (ii) receive reflected optical signals, and (iii) convert the reflected optical signals into corresponding electrical signals of the optical signals for processing by the processor into distance and orientation information with respect to the blood vessel for rendering an iconographic representation of a medical device on the display; and (2) an optical-fiber stylet configured to convey the input optical signals from the optical interrogator to a number of fiber Bragg grating (“FBG”) sensors along a length of the optical-fiber stylet and the reflected optical signals from the number of FBG sensors back to the optical interrogator, the optical-fiber stylet configured to be disposed in a lumen of the medical device.

In some embodiments, the system may further include an accelerometer, a gyroscope, a magnetometer, or a combination thereof configured to provide positional-tracking data to the console, and the processor is further configured to execute the instructions for processing the positional-tracking data to adjust of the distance of the activated ultrasonic transducers from the blood vessel, the orientation of the activated ultrasonic transducers to the blood vessel, or both the distance and the orientation of the activated ultrasonic transducers with respect to the blood vessel. In further embodiments, the distance and the orientation of the activated ultrasonic transducers is maintained with respect to the blood vessel when the ultrasound probe is inadvertently moved with respect to the blood vessel.

Also defined herein is a method as performed by an ultrasound-imaging system including a non-transitory computer-readable medium (“CRM”) having executable instructions that cause the ultrasound-imaging system to perform a set of operations for ultrasound imaging when the instructions are executed by a processor of a console of the ultrasound-imaging system. The method according to some embodiments includes: (i) activating ultrasonic transducers of an array of ultrasonic transducers of an ultrasound probe communicatively coupled to the console, whereby the ultrasonic transducers emit generated ultrasound signals into a patient, receive reflected ultrasound signals from the patient, and convert the reflected ultrasound signals into corresponding electrical signals of the ultrasound signals for processing into ultrasound images, (ii) defining an ultrasound image of a blood vessel in accordance with an image plane of the ultrasound probe, (iii) determining a misalignment between the blood vessel and the image plane, (iv) providing notification in response to determining the misalignment, and (v) rendering of the ultrasound image of a blood vessel on a display coupled with the console. In some embodiments of the method, the notification is tactile, audible, visual, or any combination thereof.

In some embodiments of the method, the ultrasound image of a blood vessel defines an elliptical shape and in further embodiments, determining the misalignment includes identifying a length and a width of the elliptical shape, calculating a parameter relating to a difference between the length and the width, and comparing the calculated parameter with a parameter limit stored in memory.

The method may further include adjusting an orientation of the activated ultrasonic transducers to orient the image plane perpendicular to the blood vessel.

In some embodiments of the method the ultrasound probe includes doppler ultrasound capability, and the method further includes determining a direction of blood flow within the blood vessel with respect the image plane based on doppler ultrasound data.

In some embodiments of the method, rendering the ultrasound image of the blood vessel includes superimposing an indicum atop the ultrasound image of the blood vessel, where the indicum indicates the direction of the blood flow.

The method may further include: (i) comparing the ultrasound image of the blood vessel with one or more ultrasound images of blood vessels stored in memory, the one or more ultrasound images pertaining to a defined medical procedure, and (ii) providing a notification when, as a result of the comparison, an orientation of the image plane of the ultrasound image of the blood vessel is determined to be opposite to the orientation of the image plane of the one or more ultrasound images. In some embodiments of the method, comparing the ultrasound image includes comparing the spatial positioning of the blood vessel in relation to adjacent anatomical elements in the ultrasound image of the blood vessel with the spatial positioning of a corresponding blood vessel in relation to corresponding adjacent anatomical elements in the one or more ultrasound images.

In some embodiments, the method further includes: (i) converting magnetic signals from a magnetized medical device with an array of magnetic sensors of the ultrasound probe into corresponding electrical signals of the magnetic signals, (ii) processing the corresponding electrical signals of the magnetic signals with the processor into distance and orientation information with respect to the blood vessel, and (iii) rendering an iconographic representation of the medical device on the display.

In some embodiments, the method further includes: (i) emitting input optical signals, receiving reflected optical signals, and converting the reflected optical signals into corresponding electrical signals of the optical signals by a stand-alone optical interrogator communicatively coupled to the console or an integrated optical interrogator integrated into the console, (ii) conveying the input optical signals from the optical interrogator to a number of fiber Bragg grating (“FBG”) sensors along a length of an optical-fiber stylet and the reflected optical signals from the number of FBG sensors back to the optical interrogator with the optical-fiber stylet disposed in a lumen of the medical device, (iii) processing the corresponding electrical signals of the optical signals with the processor into distance and orientation information with respect to the blood vessel, and (iv) rendering an iconographic representation of a medical device on the display.

In some embodiments, the method further includes adjusting the distance and orientation of the activated ultrasonic transducers with respect to a blood vessel when the medical device is brought into proximity of the ultrasound probe, thereby establishing a device image plane by the activated ultrasonic transducers perpendicular or parallel to a medical-device plane including the medical device for accessing the blood vessel with the medical device.

In some embodiments, the method further includes: providing positional-tracking data to the console from an accelerometer, a gyroscope, a magnetometer, or a combination thereof of the ultrasound probe; and processing the positional-tracking data with the processor for the adjusting of the distance of the activated ultrasonic transducers from the blood vessel or area, the orientation of the activated ultrasonic transducers to the blood vessel, or both the distance and the orientation of the activated ultrasonic transducers with respect to the blood vessel.

In some embodiments, the method further includes maintaining the distance and the orientation of the activated ultrasonic transducers with respect to the blood vessel when the ultrasound probe is inadvertently moved with respect to the blood vessel.

DESCRIPTION

With respect to “proximal,” a “proximal portion” or a “proximal-end portion” of, for example, a catheter disclosed herein includes a portion of the catheter intended to be near a clinician when the catheter is used on a patient. Likewise, a “proximal length” of, for example, the catheter includes a length of the catheter intended to be near the clinician when the catheter is used on the patient. A “proximal end” of, for example, the catheter includes an end of the catheter intended to be near the clinician when the catheter is used on the patient. The proximal portion, the proximal-end portion, or the proximal length of the catheter can include the proximal end of the catheter; however, the proximal portion, the proximal-end portion, or the proximal length of the catheter need not include the proximal end of the catheter. That is, unless context suggests otherwise, the proximal portion, the proximal-end portion, or the proximal length of the catheter is not a terminal portion or terminal length of the catheter.

With respect to “distal,” a “distal portion” or a “distal-end portion” of, for example, a catheter disclosed herein includes a portion of the catheter intended to be near or in a patient when the catheter is used on the patient. Likewise, a “distal length” of, for example, the catheter includes a length of the catheter intended to be near or in the patient when the catheter is used on the patient. A “distal end” of, for example, the catheter includes an end of the catheter intended to be near or in the patient when the catheter is used on the patient. The distal portion, the distal-end portion, or the distal length of the catheter can include the distal end of the catheter; however, the distal portion, the distal-end portion, or the distal length of the catheter need not include the distal end of the catheter. That is, unless context suggests otherwise, the distal portion, the distal-end portion, or the distal length of the catheter is not a terminal portion or terminal length of the catheter.

As set forth above, ultrasound-imaging systems and methods thereof are needed that can dynamically adjust the image plane to facilitate guiding interventional instruments to targets in at least the human body. Disclosed herein are dynamically adjusting ultrasound-imaging systems and methods thereof.

FIG.1illustrates an ultrasound-imaging system100, a needle112, and a patient P in accordance with some embodiments.FIG.2illustrates a block diagram of the ultrasound-imaging system100in accordance with some embodiments.FIG.3Aillustrates an ultrasound probe106of the ultrasound-imaging system100imaging a blood vessel of the patient P prior to accessing the blood vessel in accordance with some embodiments.FIG.3Billustrates an ultrasound image of the blood vessel ofFIG.3Aon a display screen104of the ultrasound-imaging system100with an iconographic representation of the needle112in accordance with some embodiments.

As shown, the ultrasound-imaging system100includes a console102, the display screen104, and the ultrasound probe106. The ultrasound-imaging system100is useful for imaging a target such as a blood vessel or an organ within a body of the patient P prior to a percutaneous puncture with the needle112for inserting the needle112or another medical device into the target and accessing the target. Indeed, the ultrasound-imaging system100is shown inFIG.1in a general relationship to the patient P during an ultrasound-based medical procedure to place a catheter108into the vasculature of the patient P through a skin insertion site S created by a percutaneous puncture with the needle112. It should be appreciated that the ultrasound-imaging system100can be useful in a variety of ultrasound-based medical procedures other than catheterization. For example, the percutaneous puncture with the needle112can be performed to biopsy tissue of an organ of the patient P.

The console102houses a variety of components of the ultrasound-imaging system100, and it is appreciated the console102can take any of a variety of forms. A processor116and memory118such as random-access memory (“RAM”) or non-volatile memory (e.g., electrically erasable programmable read-only memory [“EEPROM”]) is included in the console102for controlling functions of the ultrasound-imaging system100, as well as executing various logic operations or algorithms during operation of the ultrasound-imaging system100in accordance with executable logic120therefor stored in the memory118for execution by the processor116. For example, the console102is configured to instantiate by way of the logic120one or more processes for dynamically adjusting a distance of activated ultrasonic transducers149from a predefined target (e.g., blood vessel) or area, an orientation of the activated ultrasonic transducers149to the predefined target or area, or both the distance and the orientation of the activated ultrasonic transducers149with respect to the predefined target or area, as well as process electrical signals from the ultrasound probe106into ultrasound images. Dynamically adjusting the activated ultrasonic transducers149uses ultrasound-imaging data, magnetic-field data, shape-sensing data, or a combination thereof received by the console102for activating certain ultrasonic transducers of a 2-D array of the ultrasonic transducers148or moving those already activated in a linear array of the ultrasonic transducers148. A digital controller/analog interface122is also included with the console102and is in communication with both the processor116and other system components to govern interfacing between the ultrasound probe106and other system components set forth herein.

The ultrasound-imaging system100further includes ports124for connection with additional components such as optional components126including a printer, storage media, keyboard, etc. The ports124can be 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 connection128is included with the console102to enable operable connection to an external power supply130. An internal power supply132(e.g., a battery) can also be employed either with or exclusive of the external power supply130. Power management circuitry134is included with the digital controller/analog interface122of the console102to regulate power use and distribution.

The display screen104is integrated into the console102to provide a GUI and display information for a clinician during such as one-or-more ultrasound images of the target or the patient P attained by the ultrasound probe106. In addition, the ultrasound-imaging system100enables the distance and orientation of a magnetized medical device such as the needle112to 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. Notwithstanding the foregoing, the display screen104can alternatively be separate from the console102and communicatively coupled thereto. A console button interface136and control buttons110(seeFIG.1) included on the ultrasound probe106can be used to immediately call up a desired mode to the display screen104by the clinician for assistance in an ultrasound-based medical procedure. In some embodiments, the display screen104is an LCD device.

The ultrasound probe106is employed in connection with ultrasound-based visualization of a target such as a blood vessel (seeFIG.3A) in preparation for inserting the needle112or 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. As described in more detail below, the ultrasound probe106is configured to provide to the console102electrical signals corresponding to both the ultrasound-imaging data, the magnetic-field data, the shape-sensing data, or a combination thereof for the real-time ultrasound guidance.

Optionally, a stand-alone optical interrogator154can be communicatively coupled to the console102by way of one of the ports124. Alternatively, the console102can include an integrated optical interrogator integrated into the console102. Such an optical interrogator is configured to emit input optical signals into a companion optical-fiber stylet156for shape sensing with the ultrasound-imaging system100, which optical-fiber stylet156, in turn, is configured to be inserted into a lumen of a medical device such as the needle112and convey the input optical signals from the optical interrogator154to a number of FBG sensors along a length of the optical-fiber stylet156. The optical interrogator154is also configured to receive reflected optical signals conveyed by the optical-fiber stylet156reflected from the number of FBG sensors, the reflected optical signals indicative of a shape of the optical-fiber stylet156. The optical interrogator154is also configured to convert the reflected optical signals into corresponding electrical signals for processing by the console102into distance and orientation information with respect to the target for dynamically adjusting a distance of the activated ultrasonic transducers149, an orientation of the activated ultrasonic transducers149, or both the distance and the orientation of the activated ultrasonic transducers149with respect to the target or the medical device when it is brought into proximity of the target. For example, the distance and orientation of the activated ultrasonic transducers149can be adjusted with respect to a blood vessel as the target. Indeed, an image plane can be established by the activated ultrasonic transducers149being perpendicular or parallel to the blood vessel in accordance with an orientation of the blood vessel. In another example, when a medical device such as the needle112is brought into proximity of the ultrasound probe106, an image plane can be established by the activated ultrasonic transducers149being perpendicular to a medical-device plane including the medical device as shown inFIGS.11-13and21-23or parallel to the medical-device plane including the medical device for accessing the target with the medical device. The image plane can be perpendicular to the medical-device plane upon approach of the medical device and parallel to the medical-device plane upon insertion of the medical device (e.g., percutaneous puncture with the needle112). The distance and orientation information can also be used for displaying an iconographic representation of the medical device on the display.

FIG.4illustrates the ultrasound probe106of the ultrasound-imaging system100configured as a 2-D ultrasound probe106in accordance with some embodiments.FIG.14illustrates the ultrasound probe106of the ultrasound-imaging system100configured as a linear ultrasound probe106in accordance with some embodiments.

The ultrasound probe106includes a probe head114that houses a mounted and moveable (e.g., translatable or rotatable along a central axis) linear array of the ultrasonic transducers148or a 2-D array of the ultrasonic transducers148, wherein the ultrasonic transducers148are piezoelectric transducers or capacitive micromachined ultrasonic transducers (“CMUTs”). When the ultrasound probe106is configured with the 2-D array of the ultrasonic transducers148, a subset of the ultrasonic transducers148is linearly activated as needed for ultrasound imaging in accordance with ultrasound-imaging data, magnetic-field data, shape-sensing data, or a combination thereof to maintain the target in an image plane or switch to a different image plane (e.g., from perpendicular to a medical-device plane to parallel to the medical-device plane) including the target. (See, for example, the activated ultrasonic transducers149ofFIG.5A,7A,10A,12, or13.) When the ultrasound probe106is configured with the moveable linear array of the ultrasonic transducers148, the ultrasonic transducers148already activated for ultrasound imaging (e.g., a subset of the ultrasonic transducers148up to all the ultrasonic transducers148) are moved together on the moveable linear array as needed for ultrasound imaging in accordance with ultrasound-imaging data, magnetic-field data, shape-sensing data, or a combination thereof to maintain the target in an image plane established by the activated ultrasonic transducers149or switch to a different image plane including the target. (See, for example, the activated ultrasonic transducers149ofFIG.15A,17A,20A,22, or23.)

The probe head114is configured for placement against skin of the patient P proximate a prospective needle-insertion site where the activated ultrasonic transducers149in the probe head114can generate and emit the generated ultrasound signals into the patient P in a number of pulses, receive reflected ultrasound signals or ultrasound echoes from the patient P by way of reflection of the generated ultrasonic pulses by the body of the patient P, and convert the reflected ultrasound signals into corresponding electrical signals for processing into ultrasound images by the console102to which the ultrasound probe106is communicatively coupled. In this way, a clinician can employ the ultrasound-imaging system100to determine a suitable insertion site and establish vascular access with the needle112or another medical device.

The ultrasound probe106further includes the control buttons110for controlling certain aspects of the ultrasound-imaging system100during an ultrasound-based medical procedure, thus eliminating the need for the clinician to reach out of a sterile field around the patient P to control the ultrasound-imaging system100. For example, a control button of the control buttons110can be configured to select or lock onto the target (e.g., a blood vessel, an organ, etc.) when pressed for visualization of the target in preparation for inserting the needle112or another medical device into the target. Such a control button can also be configured to deselect the target, which is useful whether the target was selected by the control button or another means such as by holding the ultrasound probe106stationary over the target to select the target, issuing a voice command to select the target, or the like.

FIG.2shows that the ultrasound probe106further includes a button and memory controller138for governing button and ultrasound probe106operation. The button and memory controller138can include non-volatile memory (e.g., EEPROM). The button and memory controller138is in operable communication with a probe interface140of the console102, which includes an input/output (“I/O”) component142for interfacing with the ultrasonic transducers148and a button and memory I/O component144for interfacing with the button and memory controller138.

Also as seen inFIGS.2and3A, the ultrasound probe106can include a magnetic-sensor array146for detecting a magnetized medical device such as the needle112during ultrasound-based medical procedures. The magnetic-sensor array146includes a number of magnetic sensors150embedded within or included on a housing of the ultrasound probe106. The magnetic sensors150are configured to detect a magnetic field or a disturbance in a magnetic field as magnetic signals associated with the magnetized medical device when it is in proximity to the magnetic-sensor array146. The magnetic sensors150are also configured to convert the magnetic signals from the magnetized medical device (e.g., the needle112) into electrical signals for the console102to process into distance and orientation information for the magnetized medical device with respect to the predefined target, as well as for display of an iconographic representation of the magnetized medical device on the display screen104. (See the magnetic field B of the needle112inFIG.3A.) Thus, the magnetic-sensor array146enables the ultrasound-imaging system100to track the needle112or the like.

Though configured here as magnetic sensors, it is appreciated that the magnetic sensors150can be sensors of other types and configurations. Also, though they are described herein as included with the ultrasound probe106, the magnetic sensors150of the magnetic-sensor array146can be included in a component separate from the ultrasound probe106such as a sleeve into which the ultrasound probe106is inserted or even a separate handheld device. The magnetic sensors150can be disposed in an annular configuration about the probe head114of the ultrasound probe106, though it is appreciated that the magnetic sensors150can be arranged in other configurations, such as in an arched, planar, or semi-circular arrangement.

Each magnetic sensor of the magnetic sensors150includes three orthogonal sensor coils for enabling detection of a magnetic field in three spatial dimensions. Such 3-dimensional (“3-D”) magnetic sensors can be purchased, for example, from Honeywell Sensing and Control of Morristown, N.J. Further, the magnetic sensors150are configured as Hall-effect sensors, though other types of magnetic sensors could be employed. Further, instead of 3-D sensors, a plurality of 1-dimensional (“1-D”) magnetic sensors can be included and arranged as desired to achieve 1-, 2-, or 3-D detection capability.

Five magnetic sensors150are included in the magnetic-sensor array146so as to enable detection of a magnetized medical device such as the needle112in three spatial dimensions (e.g., X, Y, Z coordinate space), as well as the pitch and yaw orientation of the magnetized medical device itself. Detection of the magnetized medical device in accordance with the foregoing when the magnetized medical device is brought into proximity of the ultrasound probe106allows for dynamically adjusting a distance of the activated ultrasonic transducers149, an orientation of the activated ultrasonic transducers149, or both the distance and the orientation of the activated ultrasonic transducers149with respect to the target or the magnetized medical device. For example, the distance and orientation of the activated ultrasonic transducers149can be adjusted with respect to a blood vessel as the target. Indeed, an image plane can be established by the activated ultrasonic transducers149being perpendicular or parallel to the blood vessel in accordance with an orientation of the blood vessel. In another example, as shown amongFIGS.11-13and21-23, when the magnetized medical device is brought into proximity of the ultrasound probe106, an image plane can be established by the activated ultrasonic transducers149being perpendicular to a medical-device plane including the magnetized medical device for accessing the target with the magnetized medical device. While not shown, the image plane can also be established by the activated ultrasonic transducers149being parallel to the medical-device plane including the magnetized medical device for accessing the target with the magnetized medical device such as after insertion of the medical device into the patient. Note that in some embodiments, orthogonal sensing components of two or more of the magnetic sensors150enable the pitch and yaw attitude of the magnetized medical device to be determined, which enables tracking with relatively high accuracy. In other embodiments, fewer than five or more than five magnetic sensors of the magnetic sensors150can be employed in the magnetic-sensor array146. More generally, it is appreciated that the number, size, type, and placement of the magnetic sensors150of the magnetic-sensor array146can vary from what is explicitly shown here.

As shown inFIG.2, the ultrasound probe106can further include an inertial measurement unit (“IMU”)158or any one or more components thereof for inertial measurement selected from an accelerometer160, a gyroscope162, and a magnetometer164configured to provide positional-tracking data of the ultrasound probe106to the console102for stabilization of an image plane. The processor116is further configured to execute the logic120for processing the positional-tracking data for adjusting the distance of the activated ultrasonic transducers149from the target, the orientation of the activated ultrasonic transducers149to the target, or both the distance and the orientation of the activated ultrasonic transducers149with respect to the target to maintain the distance and the orientation of the activated ultrasonic transducers149with respect to the target when the ultrasound probe106is inadvertently moved with respect to the target.

It is appreciated that a medical device of a magnetizable material enables the medical device (e.g., the needle112) to be magnetized by a magnetizer, if not already magnetized, and tracked by the ultrasound-imaging system100when the magnetized medical device is brought into proximity of the magnetic sensors150of the magnetic-sensor array146or inserted into the body of the patient P during an ultrasound-based medical procedure. Such magnetic-based tracking of the magnetized medical device assists the clinician in placing a distal tip thereof in a desired location, such as in a lumen of a blood vessel, by superimposing a simulated needle image representing the real-time distance and orientation of the needle112over an ultrasound image of the body of the patient P being accessed by the magnetized medical device. Such a medical device can be stainless steel such as SS 304 stainless steel; however, other suitable needle materials that are capable of being magnetized can be employed. So configured, the needle112or the like can produce a magnetic field or create a magnetic disturbance in a magnetic field detectable as magnetic signals by the magnetic-sensor array146of the ultrasound probe106so as to enable the distance and orientation of the magnetized medical device to be tracked by the ultrasound-imaging system100for dynamically adjusting the distance of the activated ultrasonic transducers149, an orientation of the activated ultrasonic transducers149, or both the distance and the orientation of the activated ultrasonic transducers149with respect to the magnetized medical device.

During operation of the ultrasound-imaging system100, the probe head114of the ultrasound probe106is placed against skin of the patient P. An ultrasound beam152is produced so as to ultrasonically image a portion of a target such as a blood vessel beneath a surface of the skin of the patient P. (SeeFIG.3A.) The ultrasonic image of the blood vessel can be depicted and stabilized on the display screen104of the ultrasound-imaging system100as shown inFIG.3Bdespite inadvertent movements of the ultrasound probe106. Indeed, this is shown amongFIGS.5A,5B,7A,7B,8A,8B,10A, and10Bfor the ultrasound probe106configured with the 2-D array of the ultrasonic transducers148andFIGS.15A,15B,17A,17B,18A,18B,20A, and20Bfor the ultrasound probe106configured with the moveable linear array of the ultrasonic transducers148.

FIGS.5A and5Billustrate the activated ultrasonic transducers149of the 2-D array of the ultrasonic transducers148of the ultrasound probe106in accordance with some embodiments.FIGS.15A and15Billustrate the activated ultrasonic transducers149of the moveable linear array of the ultrasonic transducers148of the ultrasound probe106in accordance with some embodiments. As shown inFIG.7A, upon rotating the ultrasound probe106as might occur with an inadvertent movement of the ultrasound probe106, dynamic adjustment of the activated ultrasonic transducers149occurs to maintain the target in the image plane. Such dynamic adjustment includes deactivating certain ultrasonic transducers and activating certain other ultrasonic transducers to maintain a distance and orientation of the activated ultrasonic transducers149to the target, which stabilizes the ultrasound image as shown inFIG.7B. (CompareFIG.7Bwith5B.) Without such dynamic adjustment as shown byFIG.6A, the distance and orientation of the activated ultrasonic transducers149to the target is not maintained, which results in a different ultrasound image as shown inFIG.6B. (CompareFIG.6Bwith5B.) Likewise, as shown inFIG.17A, upon rotating the ultrasound probe106as might occur with an inadvertent movement of the ultrasound probe106, dynamic adjustment of the activated ultrasonic transducers149occurs to maintain the target in the image plane. Such dynamic adjustment includes automatically rotating the moveable linear array of the ultrasonic transducers148(within the probe head114) to maintain a distance and orientation of the activated ultrasonic transducers149to the target, which stabilizes the ultrasound image as shown inFIG.17B. (CompareFIG.17Bwith15B.) Without such dynamic adjustment as shown byFIG.16A, the distance and orientation of the activated ultrasonic transducers149to the target is not maintained, which results in a different ultrasound image as shown inFIG.16B. (CompareFIG.16Bwith15B.)

FIGS.8A and8Billustrate the activated ultrasonic transducers149of the 2-D array of the ultrasonic transducers148of the ultrasound probe106in accordance with some embodiments.FIGS.18A and18Billustrate the activated ultrasonic transducers149of the moveable linear array of the ultrasonic transducers148of the ultrasound probe106in accordance with some embodiments. As shown inFIG.10A, upon translating the ultrasound probe106as might occur with an inadvertence movement of the ultrasound probe106, dynamic adjustment of the activated ultrasonic transducers149occurs to maintain the target in the image plane. Such dynamic adjustment includes deactivating certain ultrasonic transducers and activating certain other ultrasonic transducers to maintain a distance and orientation of the activated ultrasonic transducers149to the target, which stabilizes the ultrasound image as shown inFIG.10B. (CompareFIG.10Bwith8B.) Without such dynamic adjustment as shown byFIG.9A, the distance and orientation of the activated ultrasonic transducers149to the target is not maintained, which results in a different ultrasound image as shown inFIG.9B. (CompareFIG.9Bwith8B.) Likewise, as shown inFIG.20A, upon translating the ultrasound probe106as might occur with an inadvertent movement of the ultrasound probe106, dynamic adjustment of the activated ultrasonic transducers149occurs to maintain the target in the image plane. Such dynamic adjustment includes automatically translating the moveable linear array of the ultrasonic transducers148(within the probe head114) to maintain a distance and orientation of the activated ultrasonic transducers149to the target, which stabilizes the ultrasound image as shown inFIG.20B. (CompareFIG.20Bwith18B.) Without such dynamic adjustment as shown byFIG.19A, the distance and orientation of the activated ultrasonic transducers149to the target is not maintained, which results in a different ultrasound image as shown inFIG.19B. (CompareFIG.19Bwith18B.)

The ultrasound-imaging system100is configured to detect the distance and orientation of a medical device by way of the magnetic sensors150or shape-sensing optical-fiber stylet156. By way of example, the magnetic-sensor array146of the ultrasound probe106is configured to detect a magnetic field of the magnetized medical device or a disturbance in a magnetic field due to the magnetized magnetic device. Each magnetic sensor of the magnetic sensors150in the magnetic-sensor array146is configured to spatially detect the needle112in 3-dimensional space. (SeeFIG.3A.) Thus, during operation of the ultrasound-imaging system100, magnetic field strength data of the medical device's magnetic field sensed by each magnetic sensor of the magnetic sensors150is forwarded to the processor116of the console102, which computes in real-time the distance and orientation of the magnetized medical device useful for dynamically adjusting a distance of activated ultrasonic transducers149, an orientation of the activated ultrasonic transducers149, or both the distance and the orientation of the activated ultrasonic transducers149with respect to the magnetized medical device. Again, the distance and orientation of the magnetized medical device is also for graphical display on the display screen104.

The distance or orientation of any point along an entire length of the magnetized medical device in a coordinate space with respect to the magnetic-sensor array146can be determined by the ultrasound-imaging system100using the magnetic-field strength data sensed by the magnetic sensors150. Moreover, a pitch and yaw of the needle112can also be determined. Suitable circuitry of the ultrasound probe106, the console102, or other components of the ultrasound-imaging system100can provide the calculations necessary for such distance or orientation. In some embodiments, the needle112can be tracked using the teachings of one or more patents of U.S. Pat. Nos. 5,775,322; 5,879,297; 6,129,668; 6,216,028; and 6,263,230, each of which is incorporated by reference in its entirety into this application.

The distance and orientation information determined by the ultrasound-imaging system100, together with an entire length of the magnetized medical device, as known by or input into the ultrasound-imaging system100, enables the ultrasound-imaging system100to accurately determine the distance and orientation of the entire length of the magnetized medical device, including a distal tip thereof, with respect to the magnetic-sensor array146. This, in turn, enables the ultrasound-imaging system100to superimpose an image of the needle112on an ultrasound image produced by the ultrasound beam152of the ultrasound probe106on the display screen104, as well as dynamically adjusting the activated ultrasonic transducers149. For example, the ultrasound image depicted on the display screen104can include depiction of the surface of the skin of the patient P and a subcutaneous blood vessel thereunder to be accessed by the needle112, as well as a depiction of the magnetized medical device as detected by the ultrasound-imaging system100and its orientation to the vessel. The ultrasound image corresponds to an image acquired by the ultrasound beam152of the ultrasound probe106. It should be appreciated that only a portion of an entire length of the magnetized medical device is magnetized and, thus, tracked by the ultrasound-imaging system100.

Note that further details regarding structure and operation of the ultrasound-imaging system100can be found in U.S. Pat. No. 9,456,766, titled “Apparatus for Use with Needle Insertion Guidance System,” which is incorporated by reference in its entirety into this application.

In some instances, it may be advantageous for the ultrasound-imaging system100to determine an orientation of a target blood vessel and to establish an ultrasound image plane that is oriented perpendicular to the blood vessel as shown inFIG.3Babove among others. In some instances, the ultrasound probe106, upon initial placement on the patient, may be oriented with respect to the patient such that the ultrasound probe106, including the ultrasound image plane, is disposed at an angle with respect to the target blood vessel. For example, the probe106, including the image plane, may be rotated out of alignment with the target blood vessel as illustrated inFIGS.6A,16Asuch that the shape of the blood vessel in the ultrasound image is elliptical. As such, it may be advantageous for the ultrasound-imaging system100to automatically detect the misalignment of the ultrasound probe106with respect the target blood vessel so that the probe106may manually re-oriented by the clinician or so that the149. . . may be automatically adjusted to establish orient the ultrasound image plane in perpendicular alignment with the target blood vessel.

FIG.24Aillustrates a top view of the ultrasound probe106in a first instance where the ultrasound probe106is rotated (e.g., about a longitudinal axis of the ultrasound probe106) with respect to the arm A of the patient P. As such, the image plane2404is disposed in a first misaligned orientation with respect to the target vein2401, i.e., the image plane2404is not disposed in a perpendicular orientation with respect to the target vein2401.

FIG.24Billustrates an image of a target vein image2401A as may be depicted in the ultrasound image2407in accordance with the first instance of misalignment ofFIG.24A. As a result of the first instance of misalignment of the image plane2404, a 2-D target vein image2401A of the target vein2401has a horizontally oriented elliptical shape in the ultrasound image2407.

FIG.24Cillustrates a side view of the ultrasound probe106in a second instance where the ultrasound probe106is tilted with respect to the arm A of the patient P. As such, the image plane2404is disposed in a second misaligned orientation with respect to the target vein2401, i.e., the image plane2404is gain not disposed in a perpendicular orientation with respect to the target vein2401.

FIG.24Dillustrates an image of a target vein image2401B as may be depicted in the ultrasound image2408in accordance with the second instance of misalignment ofFIG.24C. As a result of the second instance of misalignment of the image plane2404, the 2-D target vein image2401B of the target vein2401has a vertically oriented elliptical shape in the ultrasound image2408.

In the first and second misalignment instances of theFIGS.24A-24D, and combinations thereof, the target vein images2401A,2401B each define a length2411and a width2412of the elliptical shape. In the illustrated embodiment, the logic120detects the length2411and the width2412and calculates a parameter related to the misalignment of the image plane2404. In some embodiments, the parameter may be a ratio of the length2411versus the width2412(e.g., the length2411divided by the width2412). In other embodiments, parameter may be any other arithmetical calculation of the length2411and the width2412, such as a difference between the length2411and the width2412, for example. The logic120may then compare the calculated parameter with a parameter limit stored in memory and as a result of the comparison, determine that the ultrasound image plane is misaligned (i.e., not oriented perpendicular) with respect to the target vein2401when the calculated parameter exceeds the parameter limit in memory.

In some embodiments, the logic120may provide a notification to the clinician regarding the status of alignment. The notification may be audible, tactile, and/or visual. In some embodiments, the notification may indicate a magnitude of misalignment. For example, an audible notification may change volume or pitch in accordance with the magnitude of misalignment. By way of another example, a visual notification may include an indicium2420superimposed on the ultrasound image, such as a calculated angular indication of misalignment. In some embodiments, the clinician may manipulate the orientation of the ultrasound probe106into alignment with the target vein2401, i.e., so that the target vein image is round and/or so that the notification indicates sufficient alignment.

In some embodiments, the logic120may also automatically rotationally align the ultrasound image with the target vein2401. For example, as shown inFIG.7A, upon detecting misalignment of the image plane2404, the logic120may adjust the activated ultrasonic transducers149(seeFIG.7A) to rotationally align the image plane2404with the target vessel2401. Such adjustment may include deactivating certain ultrasonic transducers and activating certain other ultrasonic transducers to establish an orientation of the activated ultrasonic transducers149with respect to the target vein2401. Likewise, as shown inFIG.17A, upon detecting misalignment of the ultrasound probe106, the logic120may adjust the activated ultrasonic transducers149to rotationally align the image plane with the target vessel2401. Such adjustment includes automatically rotating the moveable linear array of the ultrasonic transducers148(within the probe head114, seeFIG.17B) to establish an orientation of the activated ultrasonic transducers149to the target vein2401.

In some embodiments, the ultrasound-imaging system100may be configured to detect a 180-degree misalignment of the ultrasound probe106/image plane2404with respect to the target blood vessel. In some instances, the orientation of the needle with respect to the direction of blood flow with a blood vessel may be defined according to medical procedure. For example, an intravenous catheter is generally inserted in the direction of blood flow, i.e., toward the heart of the patient. As such, it may be advantageous for the system100to detect the direction of the blood flow within a target blood vessel before insertion of the needle.

FIG.25Aillustrates a top view of the ultrasound probe106placed on the arm A of the patient P. Shown are a target vein2501and an artery2502extending along the arm A. According to a first instance, the ultrasound probe106is oriented with respect to the arm A of the patient P so that the front side2521of the probe106faces away from the patient P and the back side2522of the probe106faces toward the patient P. As such, the image plane2504is disposed in a first orientation with respect to the target vein2501and the artery2502so that a front side2505of the image plane2504faces upstream with respect to the blood flow within the target vein2501and downstream with respect to the blood flow within the artery2502. Similarly, a back side2506of the image plane2504faces downstream with respect to the blood flow within the target vein2501and upstream with respect to the blood flow within the artery2502. In some instances, the orientation of the ultrasound probe106and the resulting image plane2504may be consistent with a medical procedure, such as the placement of the peripherally inserted central catheter (PICC).

FIG.25Billustrates an ultrasound image2507of a target vein2501and the adjacent artery2502including the target vein image2501A and the artery image2502A. In some embodiments, the front side2505of the image plane2504may be consistent with a screen of the display104. In other words, a view of the target vein image2501A and the artery image2502A on the display104is consistent with view the target vein2501and the adjacent artery2502from the front side2505of the image plane2504. As such, target vein image2501A is a downstream view of the target vein2501and artery image2502A is an upstream view of the artery2502. Said another way, the direction of blood flow with respect to the target vein image2501A is into the screen of the display104and the direction of blood flow with respect to the artery image2502A is out of the screen of the display104.

FIGS.25C,25Dare similar to theFIGS.25A,25Bexcept that the orientation of the ultrasound106inFIGS.25C,25Dis flipped 180 degrees (opposite) with respect to the orientation of the ultrasound probe106inFIGS.25A,25Baccording to a second placement instance of the ultrasound probe106. According to the second instance, the ultrasound probe106is oriented with respect to the arm A of the patient P so that the back side2522of the probe106faces away from the patient P and the front side2521of the probe106faces toward the patient P. As such, the image plane2504is disposed in a second orientation with respect to the target vein2501and the artery2502so that a back side2506of the image plane2504faces upstream with respect to the blood flow within the target vein2501and downstream with respect to the blood flow within the artery2502. Similarly, a front side2505of the image plane2504faces downstream with respect to the blood flow within the target vein2501and upstream with respect to the blood flow within the artery2502target vein2501. Further similarly, the direction of blood flow with respect to the target vein image2501B is out of the screen of the display104and the direction of blood flow with respect to the artery image2502B is into the screen of the display104.

In the illustrated embodiment, the ultrasound probe106includes doppler ultrasound capability. As such, the ultrasound probe106may generate doppler ultrasound data pertaining to blood flow within blood vessels rendered in the ultrasound image, i.e., the target vein images2501A,2501B and the artery images2502A,2502B ofFIGS.25B and25D. The logic120may determine, from the doppler ultrasound data, the direction and/or velocity of the blood flow within the target vein2501and the artery2502. More specifically, the logic120may determine that the blood flow with respect to the target vein image2501A in theFIG.25Ais directed into the screen of the display104and that the blood flow with respect to the artery image2502A is directed out of the screen of the display104. Similarly, the logic120may determine that the blood flow with respect to the target vein image2501B in theFIG.25Bis directed out of the screen of the display104and that the blood flow with respect to the artery image2502B is directed into the screen of the display104.

Having the determined the direction of blood flow of the target vein2501, the logic120may provide a notification to the clinician as to the direction of blood flow with respect to the target vein image2501A with the ultrasound image2504. For example, the logic120may superimpose an indicum2511atop the ultrasound image2507ofFIG.25Bindicating blood flow directed into the screen of the display104consistent with the direction of the blood flow within the target vein2501from the front side of the ultrasound probe106toward the back side of the ultrasound probe106. Similarly, the logic120may superimpose an indicum2512atop the ultrasound image2508ofFIG.25Dindicating blood flow directed out of the screen. In similar fashion, the logic120may superimpose an indicum2513atop the ultrasound image2507ofFIG.25Bindicating blood flow directed out of the screen and superimpose an indicum2514atop the ultrasound image2508ofFIG.25Dindicating blood flow directed into the screen. Although the indicia2512,2513are illustrated as arrows, the indicia may take any form suitable for indicating a direction of the blood flow, including colored indicia.

In some embodiments, the indicia may be linked with a desired condition of a medical procedure. For example, in an instance where the procedure includes insertion of the needle into a target vein in a downstream direction, an indicum may indicate that insertion of the needle is allowed when the logic120determines that the direction of the blood flow with respect to the target vein image is into the screen. Conversely, in the same instance, an indicum may indicate that insertion of the needle is not allowed when the logic120determines that the direction of the blood flow with respect to the target vein image is out of the screen.

With further reference toFIGS.25A-25D, the logic120may be configured to differentiate a vein from an artery based on anatomical awareness such as a spatial awareness of a target blood vessel with respect to other blood vessels or anatomical elements. Similarly, the logic120may differentiate a target blood vessel from adjacent blood vessels based on anatomical awareness. In some embodiments, the anatomical awareness may include an awareness that the target vein2501is closer to the skin than the artery2502. By way of example, a medical procedure may include insertion of a peripherally inserted central catheter needle (PICC) within a brachial vein. The logic may compare the ultrasound image2507ofFIG.25Bwith one or more ultrasound images of brachial veins, in accordance with PICC medical procedure, stored in memory118, where the one or more ultrasound images include the spatial positioning of the brachial vein in relation to other anatomical elements such as the artery2502. As a result of the comparison, the logic20may determine with a degree of confidence (e.g., a percent probability) that the target vein image2501A is indeed an image of the brachial vein. By way of another example, a medical procedure may include insertion of a needle within a brachial vein in a downstream direction. The logic120may compare the image2507with the one or more ultrasound images stored in memory118. As a result of the comparison, the logic120may determine with a degree of confidence that the direction of the blood flow with respect to target vein image2501B is out of the screen. As such in some instances, the ultrasound image2508may be indicative that the target vein image2501B rotated 180 degrees from a desired orientation of the target vein image (e.g., the target vein image2501A ofFIG.25B). In some embodiments, in further response to the comparison, the logic120may superimpose indicia (e.g., the indicum2512) atop the ultrasound image2508ofFIG.25Dindicating the direction of blood flow with respect to the target vein image2501B.

Methods

Methods of the foregoing ultrasound-imaging systems include methods implemented in the ultrasound-imaging systems. For example, a method of the ultrasound-imaging system100includes a non-transitory CRM (e.g., EEPROM) having the logic120stored thereon that causes the ultrasound-imaging system100to perform a set of operations for ultrasound imaging when the logic120is executed by the processor116of the console102. Such a method may generally include activating operations, adjusting operations, processing operations, and displaying operations.

The activating operations include activating the ultrasonic transducers of the array of the ultrasonic transducers148of the ultrasound probe106communicatively coupled to the console102. With the activating operation, the ultrasonic transducers148emit generated ultrasound signals into the patient P, receive reflected ultrasound signals from the patient P, and convert the reflected ultrasound signals into corresponding electrical signals for processing into ultrasound images. The activating operations can include activating an approximately linear subset of the ultrasonic transducers148of a 2-D array of the ultrasonic transducers148. Alternatively, the activating operations can include activating a subset of the ultrasonic transducers148up to all the ultrasonic transducers148in the movable linear array of the ultrasonic transducers148.

The adjusting operations include adjusting (including dynamically adjusting) a distance of the activated ultrasonic transducers149from a predefined target or area, an orientation of the activated ultrasonic transducers149to the predefined target or area, or both the distance and the orientation of the activated ultrasonic transducers149with respect to the predefined target or area. For example, a dynamic adjusting operation can be in response to an orientation of a blood vessel, such as the predefined target. The adjusting operations include adjusting the orientation and/or distance of the activated ultrasonic transducers149with respect to the orientation of the blood vessel so as to establish an image plane by the activated ultrasonic transducers149perpendicular or parallel to the blood vessel.

The processing operations include processing the corresponding electrical signals of the ultrasound signals including doppler ultrasound signals into the ultrasound images.

The displaying operations include displaying images on the display104communicatively coupled to the console102including the ultrasound images.

The processing operations may further include determining a shape of a target blood vessel rendered within the ultrasound image. The determining may also include identifying a length and a width of an elliptical target blood vessel image and further include calculating a parameter related to a difference between the length and the width such as a ratio, for example. The processing operations may further include comparing the calculated parameter with a parameter limit stored in memory118and as a result of the comparison, the operations may further include providing notification that the calculated parameter exceeds the parameter limit (i.e., that the image plane is not sufficiently aligned perpendicular to the blood vessel). The notification may be visual, tactile, audible, or any combination thereof.

In some embodiments, the processing operations may include determining, from the calculated parameter, an angle of misalignment between the target blood vessel and the image plane. The adjusting operations may also include adjusting the orientation of the activated ultrasonic transducers149with respect to the orientation of the blood vessel so as to establish an image plane by the activated ultrasonic transducers149in alignment with the target blood vessel (i.e., perpendicular to the blood vessel) in response to the calculated parameter.

The processing operations may include differentiating a vein image from an artery image within the ultrasound image based on anatomical awareness such as a spatial awareness of a target blood vessel with respect to other blood vessels or anatomical elements. Similarly, the operations may include differentiating a target blood vessel from adjacent blood vessels based on anatomical awareness. In some embodiments, the logic120may compare target blood vessel image with one or more ultrasound images stored in memory118. As a result of the comparison, the logic120may determine with a degree of confidence (e.g., a percent probability) that the target blood vessel image is indeed an image of target blood vessel based on anatomical spatial awareness the target blood vessel in relation to adjacent anatomical elements, such as blood vessels, bones, and the like. In some embodiments, the logic120may determine a direction of blood flow within the target blood vessel with respect to the ultrasound image of the target blood vessel based at least partially on the anatomical awareness of the target blood vessel.

The display operations may further include rendering an indicium on the display in combination with a blood vessel image identifying the blood vessel image as an image of the target blood vessel.

The processing operations may further include receiving doppler ultrasound data from the ultrasound probe106and processing the doppler ultrasound data to determine indicating a direction and/or velocity within the target blood vessel with respect to the ultrasound image plane. The display operations may then render an indicium on the display104in combination with the ultrasound image of the target blood vessel where the indicium indicates the direction of blood flow with respect to the target blood vessel image.

As to magnetic signal-related operations, the method can include a converting operation. The converting operation includes converting magnetic signals from a magnetized medical device (e.g., the needle112) with the magnetic-sensor array146of the ultrasound probe106into corresponding electrical signals. The processing operations further include processing the corresponding electrical signals of the magnetic signals with the processor116into distance and orientation information with respect to the predefined target or area. The displaying operations further include displaying an iconographic representation of the medical device on the display screen104.

The method may further include an adjusting operation in response to the magnetic signals. The adjusting operation includes adjusting the distance and orientation of the activated ultrasonic transducers149with respect to the predefined target or area when the medical device is brought into proximity of the ultrasound probe106. The adjusting operation establishes an image plane by the activated ultrasonic transducers149perpendicular or parallel to the medical-device plane including the medical device for accessing the predefined target or area with the medical device. The establishing of the image plane can be perpendicular to the medical-device plane upon approach of the medical device and parallel to the medical-device plane upon insertion of the medical device. The image plane can include a blood vessel as the predefined target or area and the medical-device plane can include the needle112as the medical device.

The method may further include a number of optical signal-related operations in combination with further processing and displaying operations. The optical signal-related operations include emitting input optical signals, receiving reflected optical signals, and converting the reflected optical signals into corresponding electrical signals of the optical signals by the optical interrogator154. The optical signal-related operations also include conveying the input optical signals from the optical interrogator154to the number of FBG sensors along the length of the optical-fiber stylet156, as well as conveying the reflected optical signals from the number of FBG sensors back to the optical interrogator154with the optical-fiber stylet156disposed in a lumen of the medical device. The processing operation further include processing the corresponding electrical signals of the optical signals with the processor116into distance and orientation information with respect to the predefined target or area. The displaying operations further include displaying an iconographic representation of a medical device on the display104.

The method may further include an adjusting operation in response to the optical signals. The adjusting operation includes adjusting the distance and orientation of the activated ultrasonic transducers149with respect to the predefined target or area when the medical device is brought into proximity of the ultrasound probe106. The adjusting operation establishes an image plane by the activated ultrasonic transducers149perpendicular or parallel to the medical-device plane including the medical device for accessing the predefined target or area with the medical device. Again, the establishing of the image plane is perpendicular to the medical-device plane upon approach of the medical device and parallel to the medical-device plane upon insertion of the medical device. The image plane includes a blood vessel as the predefined target or area and the medical-device plane includes the needle112as the medical device.

The method can further include a data-providing operation in combination with further processing operations. The data-providing operation includes providing positional-tracking data to the console102from the accelerometer160, the gyroscope162, the magnetometer164, or a combination thereof of the ultrasound probe106. The processing operations further include processing the positional-tracking data with the processor116for the adjusting operation.

The method can further include a maintaining operation. The maintaining operation includes maintaining the distance and the orientation of the activated ultrasonic transducers149with respect to the predefined target or area when the ultrasound probe106is inadvertently moved with respect to the predefined target or area.