Patent Publication Number: US-2021169585-A1

Title: Needle-Guidance Systems, Components, and Methods Thereof

Description:
PRIORITY 
     This application claims the benefit of priority to U.S. Provisional Patent Application No. 62/943,574, filed Dec. 4, 2019, which is incorporated by reference in its entirety into this application. 
    
    
     BACKGROUND 
     Existing needle-guidance systems rely on magnetized needles for guiding needle insertions into blood vessels. Disposable needle magnetizers provided with stock needles are used to produce the magnetized needles on demand, but such needle magnetizers increase both operating costs and landfill waste. 
     Existing needle-guidance systems also rely on proper needle selection before guiding any particular needle into a blood vessel. Needle selection in such needle-guidance systems is often automated upon reading in needle-related information by disposable radiofrequency identification (“RFID”)-tag readers provided with the stock needles; however, such RFID-tag readers also increase both operating costs and landfill waste. 
     There is an ongoing need to reduce operating costs for both medical facilities and patients alike. There is also an ongoing need to reduce landfill waste for the sake of the environment. Disclosed herein are needle-guidance systems, components, and methods that address the foregoing needs. 
     SUMMARY 
     Disclosed herein is a needle-guidance system including, in some embodiments, a console, a needle magnetizer, and an ultrasound probe. The console includes memory and a processor configured to instantiate a needle-guidance process for guiding insertion of a needle into a blood vessel of a patient. The needle-guidance process uses a combination of ultrasound-imaging data and magnetic-field data received by the console for guiding the insertion of the needle into the blood vessel of the patient. The needle magnetizer is incorporated into the console. The needle magnetizer is configured to magnetize the needle. The ultrasound probe is configured to provide to the console electrical signals corresponding to both the ultrasound-imaging data and the magnetic-field data. The ultrasound probe includes an array of piezoelectric transducers and an array of magnetic sensors. The array of piezoelectric transducers is configured to convert reflected ultrasound signals from the patient into an ultrasound-imaging portion of the electrical signals. The array of magnetic sensors is configured to convert magnetic signals from the magnetized needle into a magnetic-field portion of the electrical signals. 
     In some embodiments, the needle magnetizer is removably coupled to a side, top, or back of the console. 
     In some embodiments, the needle magnetizer is irremovably coupled to a side, top, or back of the console. 
     In some embodiments, the needle magnetizer includes a single permanent magnet or a plurality of permanent magnets disposed within a body of the needle magnetizer for magnetizing the needle. 
     In some embodiments, the permanent magnets are disposed within the body of the needle magnetizer in a multipole arrangement. 
     In some embodiments, the permanent magnets are annular magnets disposed within the body of the needle magnetizer in a stacked arrangement. 
     In some embodiments, the permanent magnet is hollow cylindrical magnet disposed within the body of the needle magnetizer. 
     In some embodiments, the needle magnetizer includes a single electromagnet or a plurality of electromagnets disposed within a body of the needle magnetizer for magnetizing the needle. 
     In some embodiments, the needle-guidance system further includes an RFID-tag reader incorporated into the console. The RFID-tag reader is configured to emit interrogating radio waves into a passive RFID tag for the needle and read electronically stored information from the RFID tag. 
     In some embodiments, the needle-guidance process is configured to adjust needle-guidance parameters in accordance with the electronically stored information read from the RFID tag. 
     In some embodiments, the needle-guidance system further includes a display screen configured for graphically guiding the insertion of the needle into the blood vessel of the patient. 
     Also disclosed herein is a console for a needle-guidance system including, in some embodiments, memory and a processor, a needle magnetizer, a probe interface, and a display screen. The console is configured to instantiate a needle-guidance process in the memory for guiding insertion of a needle into a blood vessel of a patient. The needle-guidance process uses a combination of ultrasound-imaging data and magnetic-field data received by the console for guiding the insertion of the needle into the blood vessel of the patient. The needle magnetizer is incorporated into the console. The needle magnetizer is configured to magnetize the needle. The probe interface is configured to provide to the console electrical signals from an ultrasound probe. The electrical signals correspond to both the ultrasound-imaging data and the magnetic-field data. The display screen is configured for graphically guiding the insertion of the needle into the blood vessel of the patient. 
     In some embodiments, the needle magnetizer is removably coupled to a side, top, or back of the console. 
     In some embodiments, the needle magnetizer is irremovably coupled to a side, top, or back of the console. 
     In some embodiments, the needle magnetizer includes a single permanent magnet or a plurality of permanent magnets disposed within a body of the needle magnetizer for magnetizing the needle. 
     In some embodiments, the needle magnetizer includes a single electromagnet or a plurality of electromagnets disposed within a body of the needle magnetizer for magnetizing the needle. 
     In some embodiments, the console further includes an RFID-tag reader incorporated into the console. The RFID-tag reader configured to emit interrogating radio waves into a passive RFID tag for the needle and read electronically stored information from the RFID tag. 
     In some embodiments, the needle-guidance process is configured to adjust needle-guidance parameters in accordance with the electronically stored information read from the RFID tag. 
     Also disclosed herein is a method of a needle-guidance system including, in some embodiments, an instantiating step of instantiating in memory of a console a needle-guidance process for guiding insertion of a needle into a blood vessel of a patient using a combination of ultrasound-imaging data and magnetic-field data. The method further includes a magnetizing step of magnetizing the needle with a needle magnetizer incorporated into the console when the needle is inserted into the needle magnetizer. The magnetizing step produces a magnetized needle. The method further includes a loading step of loading the ultrasound-imaging data and the magnetic-field data in the memory. The ultrasound-imaging data and magnetic-field data correspond to electrical signals received from an ultrasound probe. The method further includes a processing step of processing the ultrasound-imaging data and the magnetic-field data with a processor of the console. The method further includes a guiding step of graphically guiding the insertion of the magnetized needle into the blood vessel of the patient on a display screen of the console. 
     In some embodiments, the method further includes a reading step of reading into the memory electronically stored information from a passive RFID tag for the needle. The reading step is affected with interrogating radio waves emitted by an RFID-tag reader incorporated into the console. 
     In some embodiments, the method further includes an adjusting step of adjusting needle-guidance parameters in the needle-guidance process in accordance with the electronically stored information read from the RFID tag. 
     In some embodiments, the method further includes an ultrasound-signal converting step of converting patient-reflected ultrasound signals into an ultrasound-imaging portion of the electrical signals with an array of piezoelectric transducers of the ultrasound probe. 
     In some embodiments, the method further includes a magnetic-signal converting step of converting magnetic signals into a magnetic-field portion of the electrical signals with an array of magnetic sensors of the ultrasound probe. 
     Also disclosed herein is a method for a needle-guidance system including, in some embodiments, an obtaining step of obtaining a needle. The method further includes an inserting step of inserting the needle into a needle magnetizer incorporated into a console to produce a magnetized needle. The method further includes an imaging step of imaging a blood vessel of a patient with an ultrasound probe to produce ultrasound-imaging data. The method further includes an orienting step of orienting the magnetized needle for insertion into the blood vessel of the patient to produce magnetic-field data while imaging the blood vessel with the ultrasound probe. The method further includes an inserting step of inserting the magnetized needle into the blood vessel of the patient in accordance with graphical guidance on a display screen of the console for insertion of the magnetized needle into the blood vessel of the patient. The guidance is provided by a needle-guidance process instantiated by the console upon processing a combination of the ultrasound-imaging data and the magnetic-field data. 
     In some embodiments, the method further includes a causing step of causing an RFID-tag reader incorporated into the console to read electronically stored information from a passive RFID tag for the needle before producing the magnetized needle. 
     In some embodiments, the causing step further causes the needle-guidance process to adjust needle-guidance parameters for the insertion of the magnetized needle into the blood vessel of the patient in accordance with the electronically stored information read from the RFID tag. 
     These and other features of the concepts provided herein will become more apparent to those of skill in the art in view of the accompanying drawings and following description, which describe particular embodiments of such concepts in greater detail. 
    
    
     
       DRAWINGS 
         FIG. 1  illustrates a needle-guidance system and a patient in accordance with some embodiments. 
         FIG. 2  illustrates a back of a console of a needle-guidance system in accordance with some embodiments. 
         FIG. 3  illustrates a front of the console of  FIG. 2  in accordance with some embodiments. 
         FIG. 4  illustrates another console of the needle-guidance system in accordance with some embodiments. 
         FIG. 5  illustrates another console of the needle-guidance system in accordance with some embodiments. 
         FIG. 6  illustrates another console of the needle-guidance system in accordance with some embodiments. 
         FIG. 7  illustrates a block diagram of the needle-guidance system in accordance with some embodiments. 
         FIG. 8  illustrates a catheter-insertion device including a magnetizable needle in accordance with some embodiments. 
         FIG. 9  provides an exploded view of the catheter-insertion device of  FIG. 5  in accordance with some embodiments. 
         FIG. 10  illustrates insertion of a needle into a blood vessel using an ultrasound probe of a needle-guidance system in accordance with some embodiments. 
         FIG. 11  illustrates an existing needle-guidance system along with needle packaging having a needle magnetizer and RFID-tag reader. 
     
    
    
     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. 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 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. 
     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, there is an ongoing need to reduce operating costs for both medical facilities and patients alike. There is also an ongoing need to reduce landfill waste for the sake of the environment. Disclosed herein are needle-guidance systems, components, and methods that address the foregoing needs. 
     For example, a needle-guidance system is set forth below including, in some embodiments, a console, a needle magnetizer incorporated into the console, an RFID-tag reader incorporated into the console, and an ultrasound probe. Features of the console, the needle magnetizer, the RFID-tag reader, and the ultrasound probe will become more apparent to those of skill in the art in view of the accompanying drawings and following description, which describes the foregoing needle-guidance system, as well as other embodiments in greater detail. 
     Needle-Guidance Systems 
       FIG. 1  illustrates a needle-guidance system  100  and a patient P in accordance with some embodiments.  FIGS. 2 and 3  respectively illustrate a back and a front of a console  102  of the needle-guidance system  100  in accordance with some embodiments.  FIGS. 4-6  illustrate the console  102  of the needle-guidance system  100  in accordance with some other embodiments thereof.  FIG. 7  illustrates a block diagram of the needle-guidance system  100  in accordance with some embodiments.  FIG. 10  illustrates an ultrasound probe  106  of the needle-guidance system  100  in accordance with some embodiments. 
     The needle-guidance system  100  is configured for locating and guiding a needle (e.g., the needle  808  of the catheter-insertion device  144 ) or another magnetizable medical component during ultrasound-based or other suitable procedures in order to access a subcutaneous target (e.g., blood vessel) of a patient. In some embodiments, the needle-guidance system  100  enables the position, orientation, and advancement of the needle to be superimposed in real-time atop an ultrasound image of the target, thus enabling a clinician to accurately guide the needle to the intended target. Furthermore, in some embodiments, the needle-guidance system  100  tracks a position of the needle in five degrees of motion: X, Y, and Z coordinate space, needle pitch, and needle yaw. Such tracking enables the needle to be guided and placed with relatively high accuracy. 
     As shown in  FIGS. 1-7 , the needle-guidance system  100  generally includes an ultrasound-imaging portion including the console  102 , a display screen  104 , and the ultrasound probe  106 . In addition to the ultrasound-imaging portion of the needle-guidance system  100 , the needle-guidance system  100  further includes a needle magnetizer  108  incorporated into the console  102 , an RFID-tag reader  210  incorporated into the console  102 , or both the needle magnetizer  108  and the RFID-tag reader  210  incorporated into the console  102 . 
     The ultrasound-imaging portion of the needle-guidance system  100  is employed to image a target within a body of a patient such as a blood vessel prior to percutaneous insertion of a needle (e.g., the needle  808  of the catheter-insertion device  144 ) or another magnetizable medical component to access the target. (See  FIG. 10 .) In some embodiments, insertion of the needle is performed prior to or simultaneously with insertion of a catheter (e.g., the catheter  112  of the catheter-insertion device  144 ) into a blood vessel or another portion of a vasculature of the patient P. It should be appreciated that insertion of the needle into the body of the patient P can be performed for a variety of medical purposes other than or in addition to catheter insertion. 
       FIG. 1  shows the general relation of the needle-guidance system  100  and components thereof to the patient P during a procedure to place a catheter  112  into a vasculature of the patient P through a skin insertion site S.  FIG. 1  shows that the catheter  112  generally includes a proximal portion  114  that remains exterior to the patient and a distal portion  116  that resides within the vasculature after placement is complete. The needle-guidance system  100  is employed to ultimately position a distal tip  118  of the catheter  112  in a desired position within the vasculature. 
     The proximal portion  114  of the catheter  112  further includes a Luer connector  120  configured to operably connect the catheter  112  with one or more other medical devices or systems. Placement of a needle into a vasculature of a patient such as the patient P at the insertion site S is typically performed prior to insertion of the catheter  112 . It should be appreciated the needle-guidance system  100  has a variety of uses including placement of needles in preparation for inserting the catheter  112  or other medical components into a body of a patient such as X-ray or ultrasound markers, biopsy sheaths, ablation components, bladder scanning components, vena cava filters, etc. 
     The console  102  houses a variety of components of the needle-guidance system  100  and it is appreciated that the console  102  can take any of a variety of forms. A processor  722 , including memory  724  such as random-access memory (“RAM”) and non-volatile memory (e.g., electrically erasable programmable read-only memory [“EEPROM”]) is included in the console  102  for controlling system function and executing various algorithms during operation of the needle-guidance system  100 . For example, the console  102  is configured to instantiate a needle-guidance process for guiding insertion of a needle into a target (e.g., blood vessel) of a patient. The needle-guidance process uses a combination of ultrasound-imaging data and magnetic-field data received by the console  102  for guiding the insertion of the needle into the target of the patient. A digital controller/analog interface  726  is also included with the console  102  and is in communication with both the processor  722  and other system components to govern interfacing between the ultrasound probe  106 , the needle magnetizer  108 , and the RFID-tag reader  210  and other system components. 
     The needle-guidance system  100  further includes ports  728  for connection with additional components such as optional components  730  including a printer, storage media, keyboard, etc. The ports  728  in some embodiments are universal serial bus (“USB”) ports, though other port types or a combination of port types can be used for this and the other interfaces connections described herein. A power connection  732  is included with the console  102  to enable operable connection to an external power supply  734 . An internal power supply  736  (e.g., a battery) can also be employed either with or exclusive of the external power supply  734 . Power management circuitry  738  is included with the digital controller/analog interface  726  of the console  102  to regulate power use and distribution. 
     The display screen  104  is integrated into the console  102  and is used to display information to the clinician during the placement procedure such as an ultrasound image of the targeted internal body portion attained by the ultrasound probe  106 . Indeed, the needle-guidance process of the needle-guidance system  100  graphically guides insertion of a needle into a target (e.g., a blood vessel) of a patient by way of the display screen  104 . Notwithstanding the foregoing. the display screen  104  can alternatively be separate from the console  102 . A console button interface  740  and any control buttons included on the ultrasound probe  106  can be used to immediately call up a desired mode to the display screen  104  by the clinician to assist in the placement procedure. In some embodiments, the display screen  104  is an LCD device. 
       FIG. 1  further depicts a needle-based device, namely a catheter-insertion device  144  further depicted in  FIGS. 8 and 9 , used to gain initial access to the vasculature of the patient P via the insertion site S to deploy the catheter  112 . As will be described in further detail below, the needle  808  of the catheter-insertion device  144  is configured to cooperate with the needle-guidance system  100  in enabling the needle-guidance system  100  to detect the position, orientation, and advancement of the needle  808  during an ultrasound-based placement procedure. It should be appreciated the needle  808  of the catheter-insertion device  144  is merely one example of a needle or medical device that can be magnetized and used with the needle-guidance system  100 . 
       FIGS. 1-6  also show the needle magnetizer  108  incorporated into the console  102 . The needle magnetizer  108  can be irremovably or removably coupled to a side, top, or back of the console  102 . For example,  FIGS. 1-4  illustrate the needle magnetizer  108  incorporated into a side of the console  102 . Indeed, the needle magnetizer  108  is removably coupled to the side of the console  102  by a bracket in  FIGS. 1-3  and a magnet in  FIG. 4 ; however, the needle magnetizer  108  shares a housing with that of the console  102  and is, therefore, irremovably coupled to the top of the console  102  in  FIGS. 5 and 6 . The removably coupled needle magnetizer  108  is advantageous in that it can be removed as needed for cleaning, repairing, or replacing with another needle magnetizer like the needle magnetizer  108 . That said, the irremovably coupled needle magnetizer  108  is advantageous in that it cannot be removed and misplaced. 
     The needle magnetizer  108  is configured to magnetize all or a portion of a needle such as the needle  808  of the catheter-insertion device  144  so as to enable the needle to be tracked during a placement procedure. The needle magnetizer  108  can include a single permanent magnet, a single electromagnet, a plurality of permanent magnets, a plurality of electromagnets, or a combination thereof within a body of the needle magnetizer  108  for magnetizing the needle. For example, the needle magnetizer  108  can include a single permanent magnet or a plurality of permanent magnets disposed within a body of the needle magnetizer  108  for magnetizing the needle. If a single permanent magnet, the permanent magnet can be a hollow cylindrical magnet disposed within the body of the needle magnetizer  108 . If more than one permanent magnet, the permanent magnets can be disposed within the body of the needle magnetizer  108  in a multipole arrangement. Alternatively, the permanent magnets are annular magnets disposed within the body of the needle magnetizer  108  in a stacked arrangement. 
       FIGS. 2-6  also show the RFID-tag reader  210  incorporated into the console  102 . The RFID-tag reader  210  can be incorporated into a side, top, or back of the console  102 . For example,  FIGS. 2-5  illustrate the RFID-tag reader  210  incorporated into the top of the console  102 . Indeed, the RFID-tag reader  210  is incorporated into the top of the console  102  under a housing of the console in  FIG. 4  and within a handle  212  on top of the console  102  in  FIGS. 2, 3, and 5 . In another example,  FIG. 6  illustrates the RFID-tag reader  210  incorporated into the side of the console  102 , specifically within the handle  212  on the side the console  102 . 
     The RFID-tag reader  210  is configured to read at least passive RFID tags included with needles or other medical devices (e.g., the catheter-insertion device  144 ), which enables the needle-guidance system  100  to customize its operation to particular needle or medical-device parameters (e.g., type, size, etc.). For example, the needle-guidance process, once instantiated by the needle-guidance system  100 , is configured to adjust needle-guidance parameters in accordance with electronically stored information read from an RFID tag for a needle. In order to read such an RFID tag, the RFID-tag reader is configured to emit interrogating radio waves into the RFID tag and read electronically stored information from the RFID tag. 
     The ultrasound probe  106  is employed in connection with ultrasound-based visualization of a target such as a blood vessel (see  FIG. 10 ) in preparation for insertion of a needle 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 probe  106  is configured to provide to the console  102  electrical signals corresponding to both the ultrasound-imaging data and the magnetic-field data for the real-time ultrasound guidance. 
     The ultrasound probe  106  includes a head  146  that houses an array of piezoelectric transducers. The head  146  is configured for placement against a patient&#39;s skin proximate a prospective insertion site where the head  146  can produce ultrasonic pulses by way of the array of piezoelectric transducers, receive ultrasound echoes or reflected ultrasound signals after reflection of the ultrasonic pulses by the patient&#39;s body, and convert the reflected ultrasound signals from the patient into an ultrasound-imaging portion of the foregoing electrical signals to the console  102 . In this way, a clinician can employ the ultrasound-imaging portion of the needle-guidance system  100  to determine a suitable insertion site and establish vascular access with a needle such as the needle  808  of the catheter-insertion device  144 . 
     The ultrasound probe  106  can further include control buttons for controlling certain aspects of the needle-guidance system  100  during a procedure, thus eliminating the need for a clinician to reach out of a sterile field, which is established about the patient insertion site prior to establishment of the insertion site, to control the needle-guidance system  100 . 
       FIG. 7  shows that the ultrasound probe  106  further includes a button-and-memory controller  748  for governing button and ultrasound probe operation. The button-and-memory controller  748  can include non-volatile memory (e.g., EEPROM). The button-and-memory controller  748  is in operable communication with a probe interface  750  of the console  102 , which includes a piezo input/output component  752  for interfacing with the probe piezoelectric array and a button-and-memory input/output component  754  for interfacing with the button-and-memory controller  748 . 
     Also as seen in  FIGS. 7 and 10 , the ultrasound probe  106  includes a sensor array  756  for detecting the position, orientation, and movement of a needle during ultrasound imaging procedures. The sensor array  756  includes a number of magnetic sensors  1058  embedded within or included on a housing of the ultrasound probe  106 . The magnetic sensors  1058  are configured to detect a magnetic field or magnetic signals associated with a needle when the needle is magnetized and in proximity to the sensor array  756 , as well as convert the magnetic signals from the magnetized needle into a magnetic-field portion of the foregoing electrical signals to the console  102 . (See the magnetic field B of the needle in  FIG. 10 .) Thus, the sensor array  756  enables the needle-guidance system  100  to track a magnetized needle or the like. 
     Though configured here as magnetic sensors, it is appreciated that the magnetic sensors  1058  can be sensors of other types and configurations. Also, though they are described herein as included with the ultrasound probe  106 , the magnetic sensors  1058  of the sensor array  756  can be included in a component separate from the ultrasound probe  106 , such as a separate handheld device. In some embodiments, the magnetic sensors  1058  are disposed in an annular configuration about the head  146  of the ultrasound probe  106 , though it is appreciated that the magnetic sensors  1058  can be arranged in other configurations, such as in an arched, planar, or semi-circular arrangement. 
     Each magnetic sensor of the magnetic sensors  1058  includes 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 sensors  1058  are 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 sensors  1058  are included in the sensor array  756  so as to enable detection of a needle three spatial dimensions (i.e., X, Y, Z coordinate space), as well as the pitch and yaw orientation of the needle itself. Note that in some embodiments, orthogonal sensing components of two or more of the magnetic sensors  1058  enable the pitch and yaw attitude of the needle to be determined. In other embodiments, fewer than five or more than five magnetic sensors of the magnetic sensors  1058  can be employed in the sensor array  756 . More generally, it is appreciated that the number, size, type, and placement of the magnetic sensors  1058  of the sensor array  756  can vary from what is explicitly shown here. 
     It is appreciated that a needle of a magnetizable material enables the needle to be magnetized by the needle magnetizer  108  and later be tracked by the needle-guidance system  100  when the needle is percutaneously inserted into a body of a patient (e.g., the body of the patient P) during a procedure to insert the needle or an associated medical device (e.g., the catheter  112  of the catheter-insertion device  144 ) into the body of the patient P. In some embodiments, the needle is composed of a stainless steel such as SS 304 stainless steel; however, other suitable needle materials that are capable of being magnetized can be employed. In some embodiments, the needle material is ferromagnetic. In other embodiments, the needle is paramagnetic. So configured, the needle can produce a magnetic field or magnetic signals detectable by the sensor array  756  of the ultrasound probe  106  so as to enable the location, orientation, and movement of the needle to be tracked by the needle-guidance system  100 . 
     During operation of the needle-guidance system  100 , the head  146  of the ultrasound probe  106  is placed against skin of a patient and produces an ultrasound beam  1060  so as to ultrasonically image a portion of a target such as a blood vessel beneath a surface of the skin of the patient. (See  FIG. 10 .) The ultrasonic image of the blood vessel can be depicted on the display screen  104  of the needle-guidance system  100 . 
     The needle-guidance system  100  is configured to detect the position, orientation, and movement of a needle such as the needle  808  of the catheter-insertion device  144 . In particular, the sensor array  756  of the ultrasound probe  106  is configured to detect a magnetic field of the needle after magnetization thereof. Each magnetic sensor of the magnetic sensors  1058  in the sensor array  756  is configured to spatially detect the magnetized needle in 3-dimensional space. (See  FIG. 10 .) Thus, during operation of the needle-guidance system  100 , magnetic field strength data of the needle&#39;s magnetic field sensed by each magnetic sensor of the magnetic sensors  1058  is forwarded to a processor such as the processor  722  of the console  102 , which computes in real-time the position or orientation of the needle for graphical display on the display screen  104 . 
     The position of the entire length of a needle in X, Y, and Z coordinate space with respect to the sensor array  756  can be determined by the needle-guidance system  100  using the magnetic field strength data sensed by the magnetic sensors  1058 . Moreover, the pitch and yaw of the needle can also be determined. Suitable circuitry of the ultrasound probe  106 , the console  102 , or other components of the needle-guidance system  100  can provide the calculations necessary for such position or orientation. In some embodiments, the needle can be tracked using the teachings of one or more of the following 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 position and orientation information determined by the needle-guidance system  100 , together with an entire length of a needle, as known by or input into the needle-guidance system  100  such as reading an RFID tag associated with the needle, enables the needle-guidance system  100  to accurately determine the location and orientation of the entire length of the needle, including the distal tip of the needle, with respect to the sensor array  756 . This, in turn, enables the needle-guidance system  100  to superimpose an image of the needle on an image produced by the ultrasound beam  1060  of the ultrasound probe  106  on the display screen  104 . For example, the ultrasound image depicted on the display screen  104  can include depiction of the surface of the skin of the patient P and a subcutaneous blood vessel thereunder to be accessed by the needle, as well as a depiction of the needle as detected by the needle-guidance system  100  and its position with respect to the vessel. The ultrasound image corresponds to an image acquired by the ultrasound beam of the ultrasound probe  106 . In other embodiments, it is appreciated that only a portion of the entire length of the needle is magnetized and thus tracked by the needle-guidance system  100 . 
     Note that further details regarding structure and operation of the needle-guidance system  100  can be found in U.S. Pat. No. 9,756,766, titled “Apparatus for Use with Needle Insertion Guidance System,” which is incorporated by reference in its entirety into this application. 
     A needle such as the needle  808  of the catheter-insertion device  144  can be magnetized so as to be trackable by the needle-guidance system  100  when the needle is inserted into the body of the patient P. Such magnetic-based tracking of the needle assists the clinician in placing a distal tip of the needle in a desired location, such as in the lumen of a blood vessel, by superimposing a simulated needle image representing the real-time position and orientation of the needle over an ultrasound image of the internal area of the patient body being accessed by the needle. 
     A needle can be included as part of a medical device such as the catheter-insertion device  144 , though many other implementations with other types of medical devices are contemplated. Indeed, even a stand-alone needle magnetized with the needle magnetizer  108  can be guided by the needle-guidance system  100 . 
     Catheter-Insertion Device 
       FIGS. 8 and 9  depict various details of the catheter-insertion device  144  for assistance in inserting the catheter  112  into a body of a patient, which also serves as an example of a medical device including a needle that can be magnetized and used with the needle-guidance system  100  according to some embodiments. As shown in  FIG. 8 , the catheter-insertion device  144  includes top and bottom housing portions  802  and  804  of a housing  806 , from which extends the catheter  112  disposed over a needle  808 . Also shown is a finger pad  810  of a guidewire advancement assembly  912  slidably disposed in a slot  814  defined in the top housing portion  802 , and a portion of a handle assembly  816  of a catheter advancement assembly  818 . 
       FIGS. 8 and 9  also show that the finger pad  810  as part of the guidewire advancement assembly  912  can be slid by one or more fingers of the user distally along the slot  814  in order to enable selective advancement of a guidewire  920  (initially disposed within a lumen of the needle  808 ) out past a distal end or tip  822  of the needle  808 . A proximal end of the guidewire  920  is attached to an interior portion of the top housing portion  802  such that a single unit of sliding advancement of the finger pad  810  in a distal direction results in two units of guidewire advancement in the distal direction. This is made possible by looping the guidewire  920  from its attachment point on the top housing portion  802  through guide surfaces included on a guidewire lever  924  before extending into the lumen of the needle  808 . Note that the guidewire lever  924  and the finger pad  810  of the guidewire advancement assembly  912  are integrally formed with one another, though they can be separately formed in other embodiments. Note also that the guidewire  920  can be attached to other external or internal portions of the catheter-insertion device  144 , including the bottom housing portion  804 , a needle hub  926 , etc. 
       FIGS. 8 and 9  further show that the catheter advancement assembly  818  for selectively advancing the catheter  112  in a distal direction out from the housing  806  of the catheter-insertion device  144  includes the handle assembly  816 , which in turn includes among other components two wings  928  that are grasped by the fingers of the user when the catheter  112  is to be advanced. The wings  928  distally advance via a gap defined between the top and bottom housing portions  802  and  804 . 
     The top and bottom housing portions  802  and  804  are mated together via the engagement of four tabs  930  of the top housing portion  802  with four corresponding recesses  932  located on the bottom housing portion  804 . 
     The exploded view of the catheter-insertion device  144  in  FIG. 9  shows that the handle assembly  816  includes a head portion  934  from which extend the wings  928  and a tail portion  936 . Both the head portion  934  and the tail portion  936  are removably attached to a catheter hub  938  including the Luer connector  120 . Internal components of the catheter-insertion device  144  are disposed within the housing  806 . Each component of the internal components is passed through by the needle  808 , the internal components including a valve  940 , a safety housing  942 , a carriage  944 , a needle safety component  946 , and a cap  948  of the safety housing  942 . An O-ring  950  included with the needle safety component  946  is also shown, as is the needle hub  926 , which is secured to a proximal end of the needle  808  and mounted to the housing  806  to secure the needle  808  in place within the catheter-insertion device  144 . Note in  FIG. 9  that the slot  814  in which the finger pad  810  of the guidewire advancement assembly  912  is disposed includes a relatively wide portion to enable the guidewire lever  924  to be inserted therethrough in order to couple the guidewire advancement assembly  912  to the housing  806 . 
     The catheter-insertion device  144  is used by a clinician to insert the catheter  112  into a venous system (or other location) of a patient so as to enable fluids, medicaments, etc. to be infused into or removed from a patient. Though depicted here as a midline catheter, the catheter  112  can include any catheter of a variety of lengths, including relatively shorter peripheral catheters, peripherally inserted central catheters (“PICCS”), central venous catheters (“CVCs”), etc. Also, other elongate medical devices can be employed including solid and hollow needles and cannulas, blood-draw needles, biopsy needles, introducer needles, guidewires, stylets, tissue-penetrating medical components, etc. Further details regarding the catheter-insertion device  144  and its operation can be found in U.S. Pat. No. 9,950,139, titled “Catheter Placement Device Including Guidewire and Catheter Control Elements,” which is incorporated by reference in its entirety into this application. 
     Methods 
     A method of the needle-guidance system  100  includes an instantiating step of instantiating in the memory  724  (e.g., the RAM) of the console  102  the needle-guidance process for guiding insertion of a needle into a blood vessel of a patient using a combination of ultrasound-imaging data and magnetic-field data. 
     The method can further include a magnetizing step of magnetizing the needle in accordance with a first preparatory step for the insertion of the needle into the blood vessel of the patient. The magnetizing step includes magnetizing the needle with the needle magnetizer  108  incorporated into the console  102  when the needle is inserted into the needle magnetizer  108 . The magnetizing step produces a magnetized needle. 
     The method can further include a reading step of reading electronically stored information for the needle in accordance with a second preparatory step for the insertion of the needle into the blood vessel of the patient. The reading step includes reading into the memory  724  the electronically stored information from an RFID tag for the needle. The reading step is effected with interrogating radio waves emitted by the RFID-tag reader  210  incorporated into the console  102 . After the reading step, the method can further include an adjusting step of adjusting needle-guidance parameters in the needle-guidance process in accordance with the electronically stored information read from the RFID tag. 
     With respect to the ultrasound probe  106 , the method further includes an ultrasound-signal converting step of converting patient-reflected ultrasound signals into an ultrasound-imaging portion of the electrical signals with the array of piezoelectric transducers of the ultrasound probe  106 . The method further includes a magnetic-signal converting step of converting magnetic signals into a magnetic-field portion of the electrical signals with the sensor array  756  of the magnetic sensors  1058  of the ultrasound probe  106 . 
     The method further includes a loading step of loading the ultrasound-imaging data and the magnetic-field data in the memory  724 . The ultrasound-imaging data and magnetic-field data correspond to electrical signals received from the ultrasound probe  106 . Following the loading step, the method further includes a processing step of processing the ultrasound-imaging data and the magnetic-field data with the processor  722  of the console  102  for a guiding step of the method for graphically guiding the insertion of the magnetized needle into the blood vessel of the patient on the display screen  104  of the console  102 . 
     A method associated with the needle-guidance system  100  includes an obtaining step of obtaining a needle. 
     In accordance with the first preparatory step set forth above, the method can further include an inserting step of inserting the needle into the needle magnetizer  108  incorporated into the console  102  to produce a magnetized needle. 
     In accordance with the second preparatory step set forth above, the method can further include a causing step of causing the RFID-tag reader  210  incorporated into the console  102  to read electronically stored information from an RFID tag for the needle before or after producing the magnetized needle. The causing step can include merely bringing the RFID tag into range of the RFID-tag reader  210 . The causing step further causes the needle-guidance process to adjust needle-guidance parameters for the insertion of the magnetized needle into a blood vessel of a patient in accordance with the electronically stored information read from the RFID tag. 
     As shown in  FIG. 10 , the method further includes an imaging step of imaging the blood vessel of the patient with the ultrasound probe  106  to produce ultrasound-imaging data.  FIG. 10  also shows the method further includes an orienting step of orienting the magnetized needle for insertion into the blood vessel of the patient to produce magnetic-field data while imaging the blood vessel with the ultrasound probe  106 . 
     The method can further include an inserting step of inserting the magnetized needle into the blood vessel of the patient in accordance with graphical guidance on the display screen  104  of the console  102  for insertion of the magnetized needle into the blood vessel of the patient. The guidance is provided by a needle-guidance process instantiated by the console  102  upon processing a combination of the ultrasound-imaging data and the magnetic-field data. 
     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 and/or modifications can appear to those of ordinary skill in the art, and, in broader aspects, these adaptations and/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.