Patent ID: 12232909

DESCRIPTION

Before some particular embodiments are disclosed in greater detail, it should be understood that the particular embodiments disclosed herein do not limit the scope of the concepts provided herein. It should also be understood that a particular embodiment disclosed herein can have features that can be readily separated from the particular embodiment and optionally combined with or substituted for features of any of a number of other embodiments disclosed herein.

Regarding terms used herein, it should also be understood the terms are for the purpose of describing some particular embodiments, and the terms do not limit the scope of the concepts provided herein. Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or steps in a group of features or steps, and do not supply a serial or numerical limitation. For example, “first,” “second,” and “third” features or steps need not necessarily appear in that order, and the particular embodiments including such features or steps need not necessarily be limited to the three features or steps. In addition, any of the foregoing features or steps can, in turn, further include one or more features or steps unless indicated otherwise. Labels such as “left,” “right,” “top,” “bottom,” “front,” “back,” and the like are used for convenience and are not intended to imply, for example, any particular fixed location, orientation, or direction. Instead, such labels are used to reflect, for example, relative location, orientation, or directions. Singular forms of “a,” “an,” and “the” include plural references unless the context clearly dictates otherwise.

With respect to “proximal,” a “proximal portion” or a “proximal-end portion” of, for example, a catheter 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 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.

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.

Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by those of ordinary skill in the art.

As set forth above, a range of ultrasound systems exist; however, the existing ultrasound systems include various deficiencies following from their design. Disclosed herein are portable ultrasound systems and methods that address the foregoing deficiencies.

Portable Ultrasound Systems

FIGS.1A-1C and2A-2Cprovide views of a portable ultrasound system100including a handheld computer102in a case104respectively with and without a removably coupled probe head106in accordance with some embodiments.FIGS.3A-3Cprovide views of a portable ultrasound system200including the handheld computer102in a case204with a fixedly coupled probe head206in accordance with some embodiments.FIGS.4A-4Cprovide views of the handheld computer102of the portable ultrasound system100or200in accordance with some embodiments in which the handheld computer102is removable.FIG.5provides a block diagram of the portable ultrasound system100or200in accordance with some embodiments.

The portable ultrasound system100or200includes a portable ultrasound probe and the handheld computer102, which handheld computer102can be integral with the portable ultrasound probe or removable therefrom. The description set forth below generally begins with the portable ultrasound probe, the case104or204of which is configured to accept the removable handheld computer102when inserted therein and, thereby, form the portable ultrasound system100or200. (Said differently, the portable ultrasound probe is the portable ultrasound system100or200without the handheld computer102.) However, description for the portable ultrasound system100or200including the integral or removable handheld computer102is provided where contextually convenient. Subsequent description is generally directed to the handheld computer102and the portable ultrasound system100or200, itself, whether or not the handheld computer102is integral with the portable ultrasound system100or200or removable therefrom.

The portable ultrasound probe includes the case104or204configured to hold the handheld computer102, the probe head106or206coupled to the case104or204, and a communicating means for communicating between the probe head106or206and the handheld computer102.

The case104or204can include one or more openings to accommodate one or more features of the handheld computer102while holding the handheld computer102therein. In an example, the one-or-more openings can include an anterior opening configured to frame the front-facing display132of the handheld computer102when the handheld computer102is held in the case104or204. In another example, the one-or-more openings can include a posterior opening configured to frame the rear-facing camera142of the handheld computer102when the handheld computer102is held in the case104or204.

The case104or204can include one or more side buttons108configured for providing data or control signals to the handheld computer102via button presses. For example, the one-or-more side buttons108can provide control signals when pressed for switching between longitudinal or transverse scanning with a two-dimensional (“2D”) array of ultrasonic transducers in, for example, the probe head206. The one-or-more side buttons108can be in direct communication with the handheld computer102when the handheld computer102is integral with the case104or204. That said, the one-or-more side buttons108can be in indirect communication with the handheld computer102when the handheld computer102is removable. Indeed, the one-or-more side buttons108can overlie one or more side buttons of the handheld computer102. In such embodiments, the one-or-more side buttons108of the case104or204are configured to mechanically transfer button presses to the one-or-more side buttons of the handheld computer102.

The case104or204can include a handle110incorporated into the case104or204opposite the anterior opening. The handle110is configured to facilitate holding the portable ultrasound system100or200or moving the probe head106or206thereof over skin of a patient with a single hand, left or right, in view of the handle110preferably being symmetrical. Indeed, the handle110in combination with a relatively small form factor enables the portable ultrasound system100or200to be held, moved in accordance with the foregoing, and even operated using a single hand of a clinician, which, in turn, leaves another hand of the clinician free for other related operations such as placing a medical device such as VAD (e.g., a needle, a catheter, etc.) in an anatomical target under the probe head106or206. The handle110can include a knob as shown; however, the handle110can alternatively include one or more finger loops, an adjustable touch-fastener hand strap, or the like. Notably, when the handle110is the knob, the knob can be configured to pop out from the case104or204such as from a complementarily dimensioned posterior compartment of the case104or204prior to using the portable ultrasound system100or200. The knob can be further configured to pop back into the case104or204or the posterior compartment thereof after using the portable ultrasound system100or200. In this way, the handle110of the portable ultrasound system100or200can have a smaller form factor when not being used for ultrasound imaging such as for inputting textual or graphical data in keeping patients' medical records current.

The case can104or204include a rechargeable battery112integrated into the case104or204opposite the anterior opening. The battery112is configured to provide main or backup power to the portable ultrasound system100or200including the handheld computer102, the array of ultrasonic transducers116, the array of magnetic sensors118, or the like.

The probe head106can be removably coupled to the case104as shown inFIGS.1A-1C, and the probe head206can be fixedly coupled to the case204as shown inFIGS.3A-3C. As the probe head106is removably coupled to the case104, the probe head106can be advantageously swapped out for another probe head when needed. In an example, the probe head106might be a curvilinear probe head useful for abdominal applications when a linear probe head is needed for vascular applications. The probe head106being removably coupled to the case104allows the curvilinear probe head to be swapped out for the linear probe head or vice versa if the curvilinear probe head is needed over the linear probe head. The removably coupled probe head106can be further advantageously configured to articulate. Indeed, the removably coupled probe head106can be configured to articulate in any direction about a joint114(e.g., ball joint) coupling the probe head106to the case104. That said, the fixedly coupled probe head206, too, can be advantageously configured to articulate as well.

The probe head106or206includes an array of ultrasonic transducers116disposed therein such as in a linear array, a curvilinear array, or a 2D array of ultrasonic transducers. The ultrasonic transducers of the array of ultrasonic transducers116can be piezoelectric ultrasonic transducers or capacitive micromachined ultrasonic transducers (“CMUTs”). Regardless, the array of ultrasonic transducers116in the probe head106or206can 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 by the handheld computer102.

The probe head106or206can include an array of magnetic sensors118(e.g., Hall-effect sensors) disposed therein for detecting a magnetized medical device such as a magnetized VAD (e.g., a magnetized needle) when the magnetized medical device is proximate the array of magnetic sensors118. The array of magnetic sensors118is configured to detect a magnetic field or a disturbance in a magnetic field as magnetic signals associated with the magnetized medical device. The array of magnetic sensors118is also configured to convert the magnetic signals from the magnetized medical device into electrical signals for the handheld computer102to process into distance and orientation information for the magnetized medical device with respect to a selected anatomical target under simultaneous ultrasound imaging. Advantageously, such distance and orientation information for the magnetized medical device can be used to provide haptic feedback or display an iconographic representation133of the magnetized medical device on the display screen of the display132of the handheld computer102for guided insertion of the magnetized medical device into the anatomical target.

The portable ultrasound probe can further include a needle guide120removably coupled to a needle-guide holder122of the probe head106or206. The needle guide120includes a needle through hole configured to direct a needle disposed therein into a selected anatomical target of a patient under the probe head106or206.

The communicating means for communicating between the probe head106or206and the handheld computer102can be wired or wireless. In an example, the communicating means for communicating between the probe head106or206and the handheld computer102can be a bus between the probe head106or206and a connector (e.g., a micro universal serial bus [“USB”] connector, a USB Type-C connector, etc.) disposed in the case104or204for connecting the handheld computer102when the handheld computer102is removable from the case104or204. When the handheld computer102is integral with the case104or204, however, the bus can directly connect the probe head106or206and the handheld computer102for communications therebetween. In another example, the probe head106or206includes a wireless module123disposed therein for wireless communications with a wireless module125of the handheld computer102. Notably, the wireless module125of the handheld computer102can be further configured for wireless communications with one or more remote computers for remote image processing or external display such that an external display of the one-or-more computers can duplicate or supplant the display132of the portable ultrasound system100or200.

The handheld computer102can be a dedicated device or a smartphone configured for ultrasound imaging. Indeed, whether the handheld computer102is a dedicated device or a smartphone, the handheld computer102is configured to drive the array of ultrasonic transducers116as well as process reflected ultrasound signals received by the array of ultrasonic transducers116into ultrasound images for display on the display screen of the display of the handheld computer102. Such configuration can be accomplished by hardware, software, or a combination thereof. In an example, the dedicated device can include hardware for signal processing of the reflected ultrasound signals, whereas the smartphone can include software (e.g., one or more programs or modules thereof) for signal processing of the reflected ultrasound signals. As such, it should be understood components of the handheld computer102shown inFIG.5and set forth below can vary between the dedicated device and the smartphone, particularly with respect to the combination of hardware and software for the ultrasound imaging.

As shown, the handheld computer102includes one or more processors124, primary memory126including volatile memory such as random-access memory (“RAM”) and non-volatile memory such as read-only memory (“ROM”), and secondary memory128including non-volatile memory such as flash memory (e.g., one or more flash-memory chips in combination with a flash-memory controller chip, optionally in a memory card, solid-state drive, etc.), wherein the primary memory126is directly accessible by the one-or-more processors124and the secondary memory128is not directly accessible by the one-or-more processors.

Instructions130stored in the primary memory126, the secondary memory128, or a combination thereof are configured to instantiate one or more programs or modules thereof in the RAM for ultrasound imaging. The one-or-more programs or modules thereof can include those for driving the array of ultrasonic transducers116; processing reflected ultrasound signals received by the array ultrasonic transducers116into ultrasound images; processing magnetic signals received by the array of magnetic sensors118into distance and orientation information for on-screen guidance of magnetized medical devices to anatomical targets; or providing a graphical user interface (“GUI”)135, an ultrasound image viewer, or the on-screen guidance for the magnetized medical devices to the anatomical targets for display on a display screen of a display132of the handheld computer102. In an example, the one-or-more programs or modules thereof can include a beamformer134configured to drive the array of ultrasonic transducers116as well as receive, amplify, and digitize the reflected ultrasound signals; a signal processor136configured to detect an amplitude of each of the foregoing reflected ultrasound signals or the digitized signals corresponding thereto; and an image processor138configured to manage storage of detected amplitudes and send ultrasound images corresponding to collections of the detected amplitudes to the display screen of the display132upon completion of the ultrasound images for viewing in the ultrasound image viewer. However, it should again be emphasized the one-or-more programs or modules thereof for the ultrasound imaging can alternatively be implemented in hardware.

On-screen buttons137provided by the GUI135, an optional microphone140, a camera142, and the one-or-more side buttons108or those of the handheld computer102, itself, provide various user interfaces by which a clinician can input textual or graphical data before, during, or after ultrasound imaging with the portable ultrasound system100or200. The textual data can include text entered by way of typing on an on-screen keyboard, selected by way of one or more graphical control elements (e.g., the on-screen buttons137, drop-down lists, etc.), dictated into the microphone140and processed through voice recognition software, captured by the camera142from one-dimensional (“1D”) or 2D barcodes, or the like. The graphical data can include images or videos captured with the camera142. Such textual or graphical data can be useful for effectively utilizing the portable ultrasound system100or200. For example, the textural or graphical data can include technical details for the magnetized medical device useful in providing accurate on-screen guidance while placing the magnetized medical device in an anatomical target. The textual or graphical data can also be useful in keeping patients' medical records (e.g., electronic health records [“EHRs”]) current with respect to patient identification, medication, blood samples, catheter flushes, wound-dressing changes, potential complications, etc. Advantageously, when the handheld computer102is removable, the handheld computer102can be removed from the portable ultrasound system100or200for a smaller form factor for input of the foregoing textual or graphical data. Likewise, the probe head106can decoupled from the case104for a smaller form factor for input of the textual or graphical data.

Notably, at least the on-screen buttons137provided by the GUI135and the one-or-more side buttons108or those of the handheld computer102, itself, can further provide quick controls for switching among various functions or modes of the portable ultrasound system100or200. In an example, the foregoing buttons can be configured to further provide a quick control for switching between longitudinal and transverse views corresponding to the longitudinal and transverse scanning afforded by the 2D array of ultrasonic transducers, when present, in the probe head106or206or even switching into a split screen showing both the longitudinal and transverse views. In another example, the foregoing buttons can be configured to further provide a quick control for switching between different modes of the portable ultrasound system100or200including an initial assessment mode for assessing one or more potential anatomical targets for placement of a medical device (e.g., a catheter) therein, a placement or insertion mode for placing a precursory medical device (e.g., a needle) in a selected anatomical target, a subsequent assessment mode for assessing placement of the medical device (e.g., the catheter) in the anatomical target, or a data entry mode to input the foregoing textual or graphical data.

While not shown, the portable ultrasound system100or200can further include a wired or wireless charging cradle configured to charge the battery112.

Advantageously, the portable ultrasound system100or200can be used to visualize potential anatomical targets (e.g., blood vessels) in preparation for placing a medical device in one of the potential anatomical targets. The portable ultrasound system100or200can also be used to visualize a selected anatomical target while placing the medical device therein, notably with on-screen guidance on the display screen of the display132of the handheld computer102if the medical device is magnetized and the array of magnetic sensors118are present in the probe head106or206. Notably, image processing can be used to determine if the magnetized medical device is expected to intersect with a cross section of the selected anatomical target for successful placement therein. If not, the handheld computer102can generate notifications (e.g., haptic feedback, one or more visual notifications, one or more aural notifications through a speaker of the handheld computer102, etc.) to a clinician. Fortunately, with the display132of the portable ultrasound system100or200at patient level proximate the anatomical site and the medical device to be placed therein, a clinician need not look away from the patient and across a room at another display while placing the medical device, thereby minimizing placement difficulties.

Methods

Methods of the portable ultrasound systems100and200include methods of using the portable ultrasound systems100and200. For example, a method of using the portable ultrasound system100or200includes one or more steps selected from an obtaining step, a replacing step, an attaching step, a moving step, a monitoring step, a pressing step, a creating step, an imaging step, another monitoring step, and a placing step.

The obtaining step includes obtaining the portable ultrasound system100or200. As set forth above, the portable ultrasound system100or200includes the handheld computer102including the display132, the case104or204holding the handheld computer102, and the probe head106or206coupled to the case104or204.

The replacing step includes removing the probe head106from the case104and coupling another probe head to the case104. For example, the probe head106might be a curvilinear probe head useful for abdominal application when a linear probe head is needed for vascular applications.

The attaching step includes attaching the needle guide120to the needle-guide holder122of the probe head106or206. As set forth above, the needle guide120includes the needle through hole configured to direct the needle into a patient under the probe head106or206.

The moving step includes moving the probe head106or206of the portable ultrasound system100or200over skin of the patient. For the probe head106, the moving step also includes allowing the probe head106to articulate about the joint114coupling the probe head106to the case104. While performing the moving step, the probe head106or206emits generated ultrasound signals into the patient from the array of ultrasonic transducers116in the probe head106or206and receives reflected ultrasound signals from the patient by the array of ultrasonic transducers116. Advantageously, the portable ultrasound system100or200and the probe head106or206thereof can be moved in the moving step with a single hand. As set forth above, the case104or204includes the handle110selected from the knob, the one-or-more finger loops, and the adjustable strap configured to facilitate holding the portable ultrasound system100or200or moving the probe head106or206thereof over the skin of the patient with the single hand.

The monitoring step includes monitoring ultrasound images on the display screen of the display132of the handheld computer102.

The pressing step includes pressing a side button of the one-or-more side buttons108of the case104or204to switch between longitudinal and transverse scanning when the array of ultrasonic transducers116is the 2D array of ultrasonic transducers.

The creating step includes identifying an anatomical target of the patient and inserting the needle into the anatomical target, thereby creating an access site.

The imaging step included imaging the skin of the patient through the posterior opening of the case104or204with the camera142of the handheld computer102after identifying the anatomical target thereunder and before inserting the needle into the anatomical target.

The other monitoring step includes monitoring on-screen guidance of the needle on the display screen of the display132of the handheld computer102. The probe head106or206further includes the array of magnetic sensors118configured to detect changes in a magnetic field, when the needle is magnetized, for the on-screen guidance.

The placing step includes placing the portable ultrasound system100or200in the charging cradle to charge the battery112integrated into the case104or204of the portable ultrasound system100or200.

While some particular embodiments have been disclosed herein, and while the particular embodiments have been disclosed in some detail, it is not the intention for the particular embodiments to limit the scope of the concepts provided herein. Additional adaptations or modifications can appear to those of ordinary skill in the art, and, in broader aspects, these adaptations or modifications are encompassed as well. Accordingly, departures may be made from the particular embodiments disclosed herein without departing from the scope of the concepts provided herein.